Identity
- Trade Name
- 100 mL Drainage Bag EUDAMED
- Device Name
- PVC Drainage Bag EUDAMED
- Model / Reference
- DB001 EUDAMEDDE25GS/VED-008EOX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810096151582 EUDAMED
- Basic UDI-DI
- 697226182DB0018D EUDAMED
- Direct Marketing DI
- 00810096151582 EUDAMED
- EMDN Code
- A060301 COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Negative-pressure wound therapy system canister
100 mL Drainage Bag by Ucomfor Scientific Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system canister.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697226182DB0018D | Class I | Active |
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Manufacturer
- Manufacturer
- Ucomfor Scientific Co., Ltd
- EUDAMED SRN
- CN-MF-000016602
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9816bc2f-5d89-437e-ab7b-6bbe372c66e4 61 fields · synced Oct 6, 2026