Unimed
The FDA filing describes the Unimed disposable ECG lead wire as a single-patient electrode cable system. It transmits signals from surface electrodes to electrocardiograph recorders or…
The FDA filing describes the Unimed disposable ECG lead wire as a single-patient electrode cable system. It transmits signals from surface electrodes to electrocardiograph recorders or monitors.
The filing states that the lead wires are for ECG measurement for diagnostic and monitoring purposes by trained health professionals. Use is limited by the connected equipment’s indications.
Listed Item
Prolongateurs pour holter → Banane → 5 voies → Adulte/pédiatrie fiche sécurité → L= 0,60 m Holter leadwires → Banana → 5 leads → Adult/paediatric with safety connector → L= 0,60 m
Connection and Use
The device family links a patient and a compatible patient trunk cable system. The filing specifies short-term use, described as an average patient stay of five days.
22manufacturers in China registered for this device type
5,928catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (18), Jiangsu (1), Zhejiang (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 12 |
| APK Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
| Beijing Rongrui Century Science Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 4 |
| Dongguan Rongrui-Century Science&Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Kepler Special Cabling Company Limited | Dongguan | Guangdong | Contract manufacturer | 3 |
| Palconn Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Shenzhen Redy-MED Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Showing 12 of 22. All 22 manufacturers in China registered for Cable, Transducer And Electrode, Patient, (Including Connector)
Record
| Listed by | Unimed Medical Supplies Inc, China |
|---|---|
| FDA product code | DSA |
| Device type | Cable, Transducer And Electrode, Patient, (Including Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2900 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K142489 |
| Record published | 2022-09-26 |
| Record revised | 2025-12-08 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Carton box of 10, box of 10, case of 20, case of 10, pack of 10, case of 2 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PAP5-90P | In distribution | ||
| 23112S-I | In distribution | ||
| C415-0049 | In distribution | ||
| NEPH8151 | In distribution | ||
| W700-M-17004-1.0 | In distribution | ||
| TL81615-3S | In distribution | ||
| 24130P | In distribution | ||
| TL1165-3S | In distribution | ||
| PAAB3-90P | In distribution | ||
| 21096P | In distribution | ||
| E01-11M | In distribution | ||
| E10-MT-S | In distribution | ||
| TLT816-30-14 | In distribution | ||
| LAP6-90S0 | In distribution | ||
| LAB5-90P0 | In distribution | ||
| ASM1971AE | In distribution | ||
| ED7-120S-I | In distribution | ||
| E10R-ED-P | In distribution | ||
| CL8207 | In distribution | ||
| 26144P | In distribution | ||
| E10R-SH2-B-N | In distribution | ||
| AS805M | In distribution | ||
| 2311S | In distribution | ||
| E10R-KZ1-P/I | In distribution | ||
| NESM6153 | In distribution | ||
| 23M63P | In distribution | ||
| GE-900178-003 | In distribution | ||
| 10041 | In distribution | ||
| 2-120-D10-C | In distribution | ||
| MAS-LNC-708 | In distribution | ||
| IC-DT1-BD0 | In distribution | ||
| 2396S-I | In distribution | ||
| SL-2530 | In distribution | ||
| 2395P-I | In distribution | ||
| LCL5-90P0 | In distribution | ||
| 2511S-I | In distribution | ||
| 853363 | In distribution | ||
| U037-12 | In distribution | ||
| TL8163-3G | In distribution | ||
| LW-5L69PAT | In distribution | ||
| PWC10-LB | In distribution | ||
| USOC1851S | In distribution | ||
| LQB3-90P0 | In distribution | ||
| E708-310 | In distribution | ||
| PMQA3-90S | In distribution | ||
| USOC916P | In distribution | ||
| FCSL3-90S | In distribution | ||
| LS-331 | In distribution | ||
| SL5-90S-I | In distribution | ||
| MQMB10-LP | In distribution | ||
| USOCZ00025 | In distribution | ||
| TA-25750 | In distribution | ||
| DDT-30-AD0 | In distribution | ||
| TMQ-CA-14FR | In distribution | ||
| TX-23950 | In distribution | ||
| C415-0011 | In distribution | ||
| PU708-11 | In distribution | ||
| P2580P | In distribution | ||
| S21085S | In distribution | ||
| BC-BD-MX1 | In distribution | ||
| USOCDOC10 | In distribution | ||
| CL1202 | In distribution | ||
| TC-989803173151 | In distribution | ||
| 2547S-I | In distribution | ||
| AD-NA-10(PartsSource) | In distribution | ||
| C2327S0 | In distribution | ||
| 2355P | In distribution | ||
| NLPH5252 | In distribution | ||
| AS71324 | In distribution | ||
| IBP-DR2-BD | In distribution | ||
| 2347S-I | In distribution | ||
| D5-60S | In distribution | ||
| USOC7450 | In distribution | ||
| SMMB3-90S | In distribution | ||
| U708M-48R | In distribution | ||
| U708-74NON | In distribution | ||
| D3M-90DS | In distribution | ||
| CL7201 | In distribution | ||
| U708-69 | In distribution | ||
| MQ36-21086-I | In distribution | ||
| BC-JJ-AG | In distribution | ||
| FKD4-90P-I | In distribution | ||
| E10R-SH2-P/I-Z | In distribution | ||
| C2585DS0 | In distribution | ||
| NLNV0201-S | In distribution | ||
| AA-23029 | In distribution | ||
| TC-41785 | In distribution | ||
| AE2014 | In distribution | ||
| X-AA-90P-RA-30 | In distribution | ||
| PDT5-90P | In distribution | ||
| HPA5-90P-I | In distribution | ||
| 2596S-I | In distribution | ||
| USOC1503 | In distribution | ||
| IC-SM1-BD0 | In distribution | ||
| FCDT3-90S | In distribution | ||
| TL475-3G | In distribution | ||
| E708M-48R0 | In distribution | ||
| PSL5-90S | In distribution | ||
| BC30-NK2-MX | In distribution | ||
| MM-E10R-DIX-P/I | In distribution | ||
| USOC8001 | In distribution | ||
| LLB5-90S0 | In distribution | ||
| LM5-90P0 | In distribution | ||
| U710-36MRNON | In distribution | ||
| 23029S | In distribution | ||
| USOC101001 | In distribution | ||
| U708-213 | In distribution | ||
| U708-129 | In distribution | ||
| C415-0012 | In distribution | ||
| AS73333 | In distribution | ||
| AS70307 | In distribution | ||
| PTS6-90S | In distribution | ||
| EAM-GE4-S | In distribution | ||
| TL53113-7514 | In distribution | ||
| 2326P | In distribution | ||
| PAA-2385 | In distribution | ||
| D-1307-I | In distribution | ||
| P2327P | In distribution | ||
| PAP6-90S | In distribution | ||
| 2375P | In distribution | ||
| LHT5-90S0 | In distribution | ||
| A01-05S | In distribution | ||
| AA5-90/150P | In distribution | ||
| 23118S-I | In distribution | ||
| E06-11M | In distribution | ||
| C2342RP0 | In distribution | ||
| NLPH5152-XC | In distribution | ||
| PSM5-90P | In distribution | ||
| 2322RP-IH | In distribution | ||
| AAC4-90XDP | In distribution | ||
| HTD-1586 | In distribution | ||
| TL-23960 | In distribution | ||
| LP3-90P0 | In distribution | ||
| 23129P-I | In distribution | ||
| C2395S-I0 | In distribution | ||
| 23114RS-I | In distribution | ||
| U710M-21P | In distribution | ||
| IBP-DR1-BD | In distribution | ||
| AS804E | In distribution | ||
| AAB3-90P | In distribution | ||
| U710M-48R | In distribution | ||
| TLT25199-300ITC | In distribution | ||
| CB-5L0468A | In distribution | ||
| BC-MQ-ED | In distribution | ||
| IC-SM1-MX10 | In distribution | ||
| 2340B | In distribution | ||
| CB-2008594-001-NB | In distribution | ||
| ECG.ELC.39 | In distribution | ||
| NXMA0375 | In distribution | ||
| MQMA-2382 | In distribution | ||
| SMD3-90P | In distribution | ||
| PD-1340 | In distribution | ||
| BC30-MQ-MX | In distribution | ||
| 2415P-I | In distribution | ||
| THMP-30-AD | In distribution | ||
| IC-KTN-MX0 | In distribution | ||
| USOC002502 | In distribution | ||
| AE1027 | In distribution | ||
| C415-0018 | In distribution | ||
| FCHP-2385 | In distribution | ||
| NKB3-90NP | In distribution | ||
| PC-036505-010-NB | In distribution | ||
| BCM-MR-UT | In distribution | ||
| 013-0150-00-NB | In distribution | ||
| MCU7055070 | In distribution | ||
| 2341S | In distribution | ||
| 10003 | In distribution | ||
| PSM5-90S | In distribution | ||
| 24144P | In distribution | ||
| CL2206 | In distribution | ||
| R-2397S | In distribution | ||
| T02-0386-36M | In distribution | ||
| HTD3-90NP | In distribution | ||
| C2312P0 | In distribution | ||
| C14-4BF | 10 | In distribution | |
| E712M-150 | In distribution | ||
| UNBC.SM1.UT | In distribution | ||
| U708X-74 | In distribution | ||
| P2351P | In distribution | ||
| IC-6P-MX10 | In distribution | ||
| E10R-BK1-B/I | In distribution | ||
| NLYY9015 | In distribution | ||
| L08-05-29P | In distribution | ||
| U710M-23R | In distribution | ||
| AE1012 | In distribution | ||
| LR5-90DP0 | In distribution | ||
| TL1205-3G | In distribution | ||
| U704-01P | In distribution | ||
| TC-42385-P | In distribution | ||
| 2557S-I | In distribution | ||
| BC-UT-MX | In distribution | ||
| PNKB6-90S | In distribution | ||
| E10R-SH2-S/I | In distribution | ||
| NLGE4240 | In distribution | ||
| L08-05-MP | In distribution | ||
| E06-11M | In distribution | ||
| 115020069 | In distribution | ||
| LQB5-90P0 | In distribution | ||
| 2580S-I | In distribution | ||
| H05BTL01S-A | In distribution | ||
| E2U340P | In distribution | ||
| LQA3-90P0 | In distribution | ||
| USOC00126109 | In distribution | ||
| 60-00184-01-NB | In distribution | ||
| U708M-17P | In distribution | ||
| MCU7010015NON | In distribution | ||
| SL5-90P-I | In distribution | ||
| DRE-MR5-90S | In distribution | ||
| E10-QT-B | In distribution | ||
| USOC1749-4 | In distribution | ||
| 2575P | In distribution | ||
| 22PHPA590PI | In distribution | ||
| 2550P-I | In distribution | ||
| NCPH5196-10 | In distribution | ||
| U708-03 | In distribution | ||
| 2395S-I | In distribution | ||
| CL3-90P | In distribution | ||
| FCHPB5-90P | In distribution | ||
| 0400-1100-9001 | In distribution | ||
| TL13175-3S | In distribution | ||
| BC-SM2-ED | In distribution | ||
| U708-263 | In distribution | ||
| E10R-BK2-B/I | In distribution | ||
| PWC10-LB-L | In distribution | ||
| U708-229 | In distribution | ||
| D5-60S-I | In distribution | ||
| PLL-2540 | In distribution | ||
| C2367S0 | In distribution | ||
| UTC386DIN | In distribution | ||
| SL-2596-I | In distribution | ||
| BC-WTL-ED | In distribution | ||
| E10R-HPT2-B/I | In distribution | ||
| FCD5-90P | In distribution | ||
| NXMA2911-4 | In distribution | ||
| 2553P-I | In distribution | ||
| BC-MQ-ED/2 | In distribution | ||
| USOC17003001 | In distribution | ||
| 10260 | In distribution | ||
| L04-05-29S | In distribution | ||
| TL241317I-346-10 | In distribution | ||
| DIN-RT-5-GRB-XL | In distribution | ||
| 25M85DP | In distribution | ||
| NEDA2052 | In distribution | ||
| U704-08L | In distribution | ||
| L5-RT90D0 | In distribution | ||
| MRD3-90S | In distribution | ||
| MQ-2686-I | In distribution | ||
| BC-SM1-AG | In distribution | ||
| U708-15MR | In distribution | ||
| NLGE6261-T | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AMC | LifeSync Corporation | 1,058 |
| Fogg System Company, Inc. | Fogg System Company, Inc. | 693 |
| Multi-Link™ | AirLife Finland Oy | 611 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | ConMed Corporation | 284 |
| Maguire | Maguire Enterprises, Inc. | 193 |
| MediChoice | Owens & Minor Distribution, Inc. | 160 |
| Vermed | Graphic Controls Acquisition Corporation | 159 |
| Vital Signs™ | AirLife Finland Oy | 136 |
| Multi-Link™ | Carefusion Finland 320 Oy | 136 |
| Med-link | Shenzhen MED-Link Electronics Tech Co., Ltd. | 129 |
| Conmed | ConMed Corporation | 106 |
| APK | APK Technology Co., Ltd. | 87 |
Showing 12 of 1,260. All products under Cable, Transducer And Electrode, Patient, (Including Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142489 | 2014-11-04 |
| K082959 | 2008-10-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.