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Urine collection bag
EUDAMEDClass I (EU MDR)
Ref EC-1Model Economic urine collection bag (2000ml)：REF EC-1 Luxury urine collection bag(2000ml,2600ml,4000ml): REF: LX-1,LX-2,LX-3 Urine meter(2000+200ml,2000+500ml,2600+400ml,2600+500ml): REF: UM-1,UM-2,UM-3,UM-4
Identity
- Device Name
- Urine collection bag EUDAMED
- Model / Reference
- Economic urine collection bag (2000ml)：REF EC-1 Luxury urine collection bag(2000ml,2600ml,4000ml): REF: LX-1,LX-2,LX-3 Urine meter(2000+200ml,2000+500ml,2600+400ml,2600+500ml): REF: UM-1,UM-2,UM-3,UM-4 EUDAMEDEC-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975668520105 EUDAMED
- Basic UDI-DI
- 6975668521002FP EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Urine collection bag by Changzhou Create Medical Instruments 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 | 6975668521002FP | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Create Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000027271
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED 136a655d-14b9-4e28-93aa-27410a146fc1 61 fields · synced Jun 18, 2026