Identity
- Trade Name
- AWI® EUDAMEDAWI FDA UDI
- Generic Name
- Closed-wound/centesis drainage receptacle FDA UDI
- Device Name
- Disposable irrigation bags EUDAMEDTRUNK IRRIGATION BAG FDA UDI
- Model / Reference
- 210-01 EUDAMED210-02 EUDAMEDFDA UDI
- Description
- TRUNK IRRIGATION BAG FDA UDI
Identifiers
- Catalog Number
- 210-02 FDA UDI
- Primary DI / UDI-DI
- 16957277201597 EUDAMED06957277201590 FDA UDI
- Basic UDI-DI
- 6957277221000BE EUDAMED
- Direct Marketing DI
- 16957277201597 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Awi® by Apex (Guangzhou) Tools & Orthopedics Co. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6957277221000BE | Class I | Active |
| 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 cf949a2c-2906-4633-8623-4e656744995d 61 fields · synced Jul 12, 2026
- FDA UDI e020d4aa-9cf3-413d-8038-99e3997d617b 34 fields · synced May 30, 2026