Identity
- Trade Name
- Urine Bag EUDAMED
- Device Name
- WORECZEK NA MOCZ EUDAMED
- Model / Reference
- UBCS1 EUDAMEDBE4021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975380101125 EUDAMED
- Basic UDI-DI
- 697538010UBCS1LC EUDAMED
- Direct Marketing DI
- 06975380101125 EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Urine Bag by Huaian Xiangde Medical Products 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 | 697538010UBCS1LC | Class I | Active |
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Manufacturer
- Manufacturer
- Huaian Xiangde Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000024229
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED e8fcc8d1-90d4-4583-9268-99745f94b617 61 fields · synced Oct 6, 2026