Identity
- Trade Name
- AWI® EUDAMEDAWI FDA UDI
- Generic Name
- Closed-wound/centesis drainage receptacle FDA UDI
- Device Name
- Disposable irrigation bags EUDAMEDEXTREMITY IRRIGATION BAG FDA UDI
- Model / Reference
- 210-01 EUDAMEDFDA UDI
- Description
- EXTREMITY IRRIGATION BAG FDA UDI
Identifiers
- Catalog Number
- 210-01 FDA UDI
- Primary DI / UDI-DI
- 16957277201580 EUDAMED06957277201583 FDA UDI
- Basic UDI-DI
- 6957277221000BE EUDAMED
- Direct Marketing DI
- 16957277201580 EUDAMED
- FDA Product Code
- FON FDA UDI
- EMDN Code
- A060301 COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE EUDAMED
- GMDN Term
- Closed-wound/centesis drainage receptacle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5900 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Negative-pressure wound therapy system canister
Awi® by Apex (Guangzhou) Tools & Orthopedics Co. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system canister.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6957277221000BE | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Apex (Guangzhou) Tools & Orthopedics Co.
- EUDAMED SRN
- CN-MF-000018403
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 51018338-e994-415a-936f-2177df4d8e7b 61 fields · synced Jun 12, 2026
- FDA UDI 21f958ca-deeb-4959-969b-c4234def0a5d 34 fields · synced May 29, 2026