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Two-Piece Urostomy Bag
EUDAMEDClass I (EU MDR)
Ref 84004Model 71205,71206,10385A,71208,73002,84001,84004,73301,1758,71201,71202,10386A,71204,10386E,73006,1759-N10,11856,84002,73303,71209,71210,10387A,71212,73004Ref 1759-N10Ref 84001
Identity
- Trade Name
- Two-Piece Urostomy Bag EUDAMED
- Device Name
- Two-Piece Ostomy Bag EUDAMED
- Model / Reference
- 71205,71206,10385A,71208,73002,84001,84004,73301,1758,71201,71202,10386A,71204,10386E,73006,1759-N10,11856,84002,73303,71209,71210,10387A,71212,73004 EUDAMED84004 EUDAMED1759-N10 EUDAMED84001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975700084299 EUDAMED06975700083858 EUDAMED06975700084282 EUDAMED
- Basic UDI-DI
- 6975700082POstomyBagDW EUDAMED
- Direct Marketing DI
- 06975700084299 EUDAMED
- EMDN Code
- A10020401 UROSTOMY BAGS FOR TWO-PART SYSTEMS, W/O TISSUE COVER EUDAMEDA10020402 UROSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDSlovenia 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
Two-Piece Urostomy Bag by Concarey Medical Technology 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 | 6975700082POstomyBagDW | Class I | Active |
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Manufacturer
- Manufacturer
- Concarey Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000035609
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED 647ae9b6-90cd-44cd-aed0-5122f2286304 61 fields · synced Jul 27, 2026
- EUDAMED 330adfae-02f6-488a-ab52-0b53e8e8148d 61 fields · synced Jul 12, 2026
- EUDAMED c50fcd3b-e985-4fd5-884b-4aa7e543e86e 61 fields · synced Jul 14, 2026
- EUDAMED 4e845ff8-4fda-43c5-85ca-5731888210e3 61 fields · synced Jul 27, 2026