Exact Medical Manufacturing, Inc.
Manufacturer and brand owner in Changzhou, Jiangsu, China. 17 device types, 10 products catalogued, 9 clearances.
Exact Medical Manufacturing, Inc. is a contract manufacturer holding a current FDA establishment registration. The registration covers Bag, Ice, Gown, Surgical and 15 other device types. 10 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
17device types registered with the FDA
10products catalogued under its own name
9510(k) clearances
18recalls
Registration
| Registered name | EXACT MEDICAL MANUFACTURING, INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013443304 |
| FEI number | 3013443304 |
| DUNS | 014464314 |
| Establishment type | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | 21# Qingjiang Road |
| Postal code | 213022 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | FaceDrape, Wide, Self Donning Tabs, Face Shield 9″ long x 13″ wide w/Drape- 13″x 13″, Compression Garment, Face Shield, attahced with Full Covering, Face Shield and 1 more | 2017 | 439 |
| Autofluorescence Imaging Adjunct Tool For Wounds | Class 2 | DX Dark Drape | 2021 | 1 |
| Bag, Ice | Class 1 | Ice Pack, Ice Compression Bandage, Hays Innovation Anchor Sound Device | 2017 | 86 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Urological Drain Bag / Uro-Catcher Bag | 2025 | 52 |
| Counter, Sponge, Surgical | Class 1 | SurgiCount®+ Sponge Counting Bag, SurgiCount®+ Reader Cover | 2024 | 17 |
| Drape, Surgical, Antimicrobial | Class 2 | Surgical Drape With Aami Liquid Barrier Level IV, EMM Surgical Drape SMS W/PE Sides, EMM Equipment Cover-Polythylene, DrillCover – SteriGo, Sterile Drapes Autoguide 15 pack, EMM Surgical Drape-Spunlace W/PE Sides | 2017 | 39 |
| Drape, Surgical, Exempt | Class 2 | Tauro Towel, Film Table Cover, CG-SM, CG-SM-M – Ultrasound SuperProbe Cover Kit – Clear Guide Medical DL D361619, Transport Pad, DropStop Kit, BTC (Back Table Cover) and 7 more | 2018 | 107 |
| Gown, Surgical | Class 2 | EMM Surgical Gown-SMS With PE Layer, EMM Surgical Gown – Spunlace With PE Layer, EMM High Performance Surgical Gown With Aami Liquid Barrier Level IV, Modular Toga | 2017 | 68 |
| Instrument, Manual, Surgical, General Use | Class 1 | Z-Friction Drape, Anti-Fog Scope Warmer | 2017 | 110 |
| Kit, Surgical Instrument, Disposable | Class 1 | Kit, Convenience | 2019 | 67 |
| Shield, Protective, Personnel | Class 1 | Disposable Arm/Femoral Drape, Flipper Shield, Peripheral Shield, Halo Shield | 2024 | 78 |
| Syringe, Irrigating (Non Dental) | Class 1 | Syringe, Luer Slip | 2022 | 110 |
| Tourniquet, Nonpneumatic | Class 1 | Tourniquet | 2023 | 124 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | Probe Cover, Transducer Cover, Ultrasound Probe Cover, Ultrasound Cover, Intraoperative Probe Cover, Transducer Cover, Probe Cover | 2021 | 44 |
| Tubing, Noninvasive | Class 2 | SmokeStop | 2022 | 33 |
| Wound Autofluorescence Imaging Device | Class 1 | Dark Drape | 2018 | 1 |
| Wrap, Sterilization | Class 2 | 34″x24″ Paper Filter w/ Foam Gasket | 2017 | 38 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Exact Medical Manufacturing, Inc. | KKX | 819 |
| Exact Medical Manufacturing, Inc. | FYA | 107 |
| Exact Medical Manufacturing, Inc. | ITX | 42 |
| Exact Medical Manufacturing, Inc. | PUI | 8 |
| Exact Medical Manufacturing, Inc. | FAQ | 7 |
| Exact Medical Manufacturing, Inc. | KPY | 5 |
| Exact Medical Manufacturing, Inc. | LYU | 4 |
| Exact Medical Manufacturing, Inc. | HMW | 2 |
| Proficient Surgical | KKX | 1 |
| Proficient Surgical | ITX | 1 |
Clearances
9 clearances name Exact Medical Manufacturing, Inc. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K222460 | 2023-05-12 | ITX | Traditional | This company |
| K211969 | 2021-08-13 | ITX | Traditional | This company |
| K121919 | 2013-02-14 | KKX | Traditional | This company |
| K120045 | 2012-06-12 | FYA | Traditional | This company |
| K111535 | 2011-08-26 | FYA | Traditional | This company |
| K101598 | 2010-10-04 | KKX | Traditional | This company |
| K101688 | 2010-09-20 | KKX | Traditional | This company |
| K101689 | 2010-09-20 | KKX | Traditional | This company |
| K101593 | 2010-09-03 | FYA | Traditional | This company |
| DEN180008 | 2018-07-31 | QCR | Direct | Moleculight Inc. |
Recalls
18 of these are Class II. Class II means a temporary or reversible health consequence. 18 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 800 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 7920 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 10020 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 500 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 17545 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 9680 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 3000 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 36000 | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 6000 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 12650 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 100600 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 1600 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 5621 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 78000 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 129600 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 51300 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 33250 units | 2022-05-26 |
| 2021-04-29 | Class II | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body | 8800 units | 2022-05-26 |
Nearby Manufacturers
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.
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