Technomed Europe
8735-0060 contains the following devices: Premium Neuro Single Kit 1x BTP2.3-160 Pouch UDI 08720791378837 2x TE/Q96-832 Pouch UDI 08720791378813 1x TE/Q95-931 Pouch UDI 08718375866092 16x…
8735-0060 contains the following devices: Premium Neuro Single Kit 1x BTP2.3-160 Pouch UDI 08720791378837 2x TE/Q96-832 Pouch UDI 08720791378813 1x TE/Q95-931 Pouch UDI 08718375866092 16x TE/S50722-003-K pouch UDI 08720791378868 1x TE/K50433-025 pouch UDI 08720791371470 1x TE/S56-638 pouch UDI 08720791372064
4manufacturers in China registered for this device type
114catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
Record
| Listed by | Technomed Engineering B.V. |
|---|---|
| FDA product code | GXZ |
| Device type | Electrode, Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1350 |
| 510(k) | K241045 |
| Record published | 2016-09-22 |
| Record revised | 2025-02-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Shelfbox of 25, shelfbox of 24, pouch, shelfbox of 10, pack of 25, shelfbox of 20 |
| Sizes | Outer diameter 0.3 to 0.6 mm; needle gauge 23 to 30 G; length 6 to 75 mm; length 1.2 to 19 m |
| Distribution end date | 2023-10-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TE/AD2535-008 | Length 25 mm | In distribution |
| TE/B50700-001 | In distribution | |
| MP200/1 | In distribution | |
| DIS2.0/10 | In distribution | |
| TE/B50600-003 | Length 37 mm | In distribution |
| TE/AP7545-335 | Length 75 mm | In distribution |
| BIP100/10 | In distribution | |
| TE/S50715-003 | Length 2.5 m | In distribution |
| TE/S50721-004 | Length 14 mm | In distribution |
| TE/S50722-003-K | Outer Diameter 0.38 mm | In distribution |
| TE/S49-638 | Length 19 mm | In distribution |
| TE/S44-837 | Length 13 mm | In distribution |
| TE/S43-838 | Length 13 mm | In distribution |
| TE/S50725-004-C | Outer Diameter 0.60 mm | In distribution |
| NP003-1 | In distribution | |
| TE/S50715-002 | Length 2 m | In distribution |
| TE/S50725-002 | Outer Diameter 0.60 mm | In distribution |
| MP200/10 | In distribution | |
| TE/S50715-002-C | Length 2 m | In distribution |
| TE/B50600-006 | Length 30 mm | In distribution |
| TE/S50719-001 | Length 12 mm | In distribution |
| BTP2.3-200/1 | In distribution | |
| TE/S50722-005 | Outer Diameter 0.38 mm | In distribution |
| TE/S50715-003 | Length 2.5 m | In distribution |
| TE/B50600-005 | Length 75 mm | In distribution |
| TE/S43-438/02 | Length 13 mm | In distribution |
| TE/AP5045-335/01 | Length 50 mm | In distribution |
| TE/S50725-002 | Outer Diameter 0.60 mm | In distribution |
| TE/S50721-003 | Length 14 mm | In distribution |
| TE/S43-638 | Length 13 mm | In distribution |
| 202465-000 | Length 25 mm | In distribution |
| BTP3.0-200/1 | In distribution | |
| TE/S50719-003 | Length 12 mm | In distribution |
| TE/S50716-001 | Length 14 mm | In distribution |
| TE/S50725-001 | Outer Diameter 0.60 mm | In distribution |
| TE/AP3735-335 | Length 37 mm | In distribution |
| TE/S50719-002 | Length 12 mm | In distribution |
| TE/S44-637 | Length 13 mm | In distribution |
| 202469-000 | Length 75 mm | In distribution |
| TE/S50718-002 | Length 7 mm | In distribution |
| TE/B50600-001 | Length 25 mm | In distribution |
| BIP100/1 | In distribution | |
| TE/S46-638/01 | Needle Gauge 27 G | In distribution |
| TE/B50700-002 | In distribution | |
| 202460-000 | Needle Gauge 26 G | In distribution |
| MP100/10 | In distribution | |
| TE/S50725-003-C | Outer Diameter 0.60 mm | In distribution |
| TE/S50715-002-C | Length 2 m | In distribution |
| TE/S50715-002 | Length 2 m | In distribution |
| BTP2.3-130/1 | In distribution | |
| TE/S50725-004-C | Outer Diameter 0.60 mm | In distribution |
| 4014-00 | In distribution | |
| TE/S50715-003-C | Length 2.5 m | In distribution |
| BTP2.3-130/10 | In distribution | |
| TE/S48-637 | Length 14 mm | In distribution |
| TE/S50721-001 | Length 14 mm | In distribution |
| TE/S44-937 | Length 13 mm | In distribution |
| CP100/1 | In distribution | |
| TE/AP3745-335/01 | Length 37 mm | In distribution |
| TE/S49-838 | Length 19 mm | In distribution |
| TE/S50723-002 | Outer Diameter 0.45 mm | In distribution |
| TE/S50725-003-C | Outer Diameter 0.60 mm | In distribution |
| TE/B50600-002 | Length 25 mm | In distribution |
| 202467-000 | Length 37 mm | In distribution |
| TE/S50721-002 | Length 14 mm | In distribution |
| TE/S50722-002 | Outer Diameter 0.38 mm | In distribution |
| TE/S48-837 | Length 14 mm | In distribution |
| BTP3.0-100/1 | In distribution | |
| TE/S50725-002-C | Outer Diameter 0.60 mm | In distribution |
| BTP3.0-100/10 | In distribution | |
| TE/AP2535-335/01 | Length 25 mm | In distribution |
| TE/B50600-002 | Length 25 mm | In distribution |
| DIS201 | In distribution | |
| 202458-000 | Needle Gauge 30 G | In distribution |
| TE/S50715-003-C | Length 2.5 m | In distribution |
| 8735-0050 | In distribution | |
| TE/S48-937 | Length 14 mm | In distribution |
| TE/B50600-003 | Length 37 mm | In distribution |
| TE/AP2545-335 | Length 25 mm | In distribution |
| TE/B50600-001 | Length 25 mm | In distribution |
| BTP3.0-200/10 | In distribution | |
| BTP2.3-200/10 | In distribution | |
| TE/S50725-002-C | Outer Diameter 0.60 mm | In distribution |
| TE/S43-438 | Length 13 mm | In distribution |
| TE/S43-938 | Length 13 mm | In distribution |
| TE/B50600-005 | Length 75 mm | In distribution |
| MP100/1 | In distribution | |
| TE/B50600-006 | Length 30 mm | In distribution |
| TE/S50722-003 | Outer Diameter 0.38 mm | In distribution |
| CP100/10 | In distribution | |
| MP214-3.0/1 | In distribution | |
| 202456-000 | Needle Gauge 30 G | In distribution |
| TE/B50700-004 | In distribution | |
| BTP2.3-160/1 | In distribution | |
| 8735-0060 | In distribution | |
| TE/S50718-003 | Length 7 mm | In distribution |
| TE/S50725-004-C | Outer Diameter 0.60 mm | In distribution |
| TE/D13-301 | Length 30 mm | Withdrawn |
| TE/B50600-006 | Length 30 mm | Withdrawn |
| TE/B50035-005 | Length 75 mm | Withdrawn |
| TE/D14-501 | Length 40 mm | Withdrawn |
| TE/S51-434 | Length 13 mm | Withdrawn |
| TE/B50600-002 | Length 25 mm | Withdrawn |
| TE/B50600-001 | Length 25 mm | Withdrawn |
| TE/D225-301 | Length 25 mm | Withdrawn |
| TE/D12-301 | Length 20 mm | Withdrawn |
| TE/B50035-002 | Length 25 mm | Withdrawn |
| TE/B50035-001 | Length 25 mm | Withdrawn |
| TE/D16-601 | Length 60 mm | Withdrawn |
| TE/B50035-003 | Length 37 mm | Withdrawn |
| TE/D15-301 | Length 50 mm | Withdrawn |
| TE/D125-101 | Length 25 mm | Withdrawn |
| TE/D24-301 | Length 40 mm | Withdrawn |
| TE/B50035-004 | Length 50 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rhythmlink® | Rhythmlink International, LLC | 204 |
| Electrode, Needle | Medtronic Xomed, Inc. | 82 |
| Horizon™ | Rochester Electro Medical, Inc. | 68 |
| Spes Medica Subdermal Needle Electrodes | Spes Medica Srl | 66 |
| Friendship Medical | Xi’an Friendship Medical Electronics Co., Ltd. | 66 |
| Cadwell | Technomed Engineering B.V. | 61 |
| The Electrode Store | Impulse Technology LLC | 56 |
| Horizon™ | LifeSync Corporation | 55 |
| Rochester | Rochester Electro Medical, Inc. | 41 |
| Temena | Temena GmbH | 34 |
| Cadwell | Xi’an Friendship Medical Electronics Co., Ltd. | 33 |
| Neurosign V4 | Technomed Engineering B.V. | 30 |
Showing 12 of 106. All products under Electrode, Needle
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.