Identity
- Trade Name
- Urinary Drainage Bag EUDAMED
- Device Name
- Sterile Urinary Drainage Bags EUDAMED
- Model / Reference
- M06010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719883633729 EUDAMED
- Basic UDI-DI
- 471096971TCF05I0101EV EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Urinary Drainage Bag by Pacific Hospital Supply Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 471096971TCF05I0101EV | Class I | Active |
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Manufacturer
- Manufacturer
- Pacific Hospital Supply Co., Ltd.
- EUDAMED SRN
- TW-MF-000007247
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED c5928182-f7ed-4163-bd7a-64e8f56666a6 61 fields · synced Jul 9, 2026