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Reservoir bag
EUDAMEDClass IIa (EU MDR)
Ref CP635102Model 600ml,1600ml,2000ml,2500mlRef RRB0101004Ref CP635103Ref TM01-035-2000Ref RRB0101005Ref RRB0101006Ref RRB0101001
Identity
- Trade Name
- Reservoir bag EUDAMED
- Device Name
- Reservoir bag EUDAMED
- Model / Reference
- 600ml,1600ml,2000ml,2500ml EUDAMEDCP635102 EUDAMEDRRB0101004 EUDAMEDCP635103 EUDAMEDTM01-035-2000 EUDAMEDRRB0101005 EUDAMEDRRB0101006 EUDAMEDRRB0101001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430418616 EUDAMED06946430422217 EUDAMED06946430418609 EUDAMED06946430414885 EUDAMED06946430419484 EUDAMED06946430414892 EUDAMED06946430416360 EUDAMED06946430416377 EUDAMED06946430422170 EUDAMED06946430419842 EUDAMED06946430425911 EUDAMED
- Basic UDI-DI
- 694643041048601NC EUDAMED
- EMDN Code
- R03020199 VENTILATION BALLOONS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMEDItaly EUDAMEDSpain 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
Reservoir bag by Xiamen Compower Medical Tech. Co., Ltd. — Class IIa — 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 | 694643041048601NC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000011703
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (11)
- EUDAMED 50ff175e-86e6-4bac-b90b-4d7cca93c01b 61 fields · synced Aug 2, 2026
- EUDAMED 4fc061af-75a6-4e9a-85fc-18c37145ecaa 61 fields · synced May 16, 2026
- EUDAMED cc09a0fb-6707-4426-9905-242ed333a148 61 fields · synced May 17, 2026
- EUDAMED 783ff6bd-fbc3-42d3-ad01-cc28bb5c69d4 61 fields · synced May 17, 2026
- EUDAMED 4cb83ca2-c0a2-4287-a1ae-2f1297885845 61 fields · synced May 17, 2026
- EUDAMED 816635a5-0599-4364-ab76-0244ad064b73 61 fields · synced May 18, 2026
- EUDAMED db811aba-4753-474b-b3e4-dba8d43381af 61 fields · synced May 18, 2026
- EUDAMED 91bd358d-ca07-4361-8f6a-1abe008b2013 61 fields · synced May 19, 2026
- EUDAMED 6b24bcb5-b272-4b9f-83aa-b58618252eea 61 fields · synced May 19, 2026
- EUDAMED 6e91100c-fddd-4a56-81c0-797e4f023a2b 61 fields · synced May 19, 2026
- EUDAMED ab122ca2-185f-46ec-b9da-791c4b3eab7c 61 fields · synced Aug 2, 2026