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Ostomy Bag(Colostomy Bag or Urine Bag or Water Proof Bag or Dry Bag)
EUDAMEDClass I (EU MDR)
Ref MDR
Identity
- Device Name
- Ostomy Bag(Colostomy Bag or Urine Bag or Water Proof Bag or Dry Bag) EUDAMED
- Model / Reference
- MDR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970437240772 EUDAMED
- Basic UDI-DI
- 69704372426114XD EUDAMED
- EMDN Code
- A1001010101 ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, W/O TISSUE COVER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ostomy Bag(Colostomy Bag or Urine Bag or Water Proof Bag or Dry Bag) by Wenzhou Celecare Medical lnstruments Co., Ltd. — Class I — MDR — listed in EUDAMED
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 | 69704372426114XD | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Celecare Medical lnstruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000024264
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 4405a594-ba95-4432-8c8e-fe08cc672ebf 61 fields · synced Jun 18, 2026