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Disposable Urine Bag
EUDAMEDClass I (EU MDR)
Ref JI-1000Model JI-1000,JI-2000,JI-601,JI602,JI-603,JI604
Identity
- Device Name
- DISPOSABLE URINE BAG EUDAMED
- Model / Reference
- JI-1000,JI-2000,JI-601,JI602,JI-603,JI604 EUDAMEDJI-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978186661213 EUDAMED
- Basic UDI-DI
- 697818666MKS010W4 EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Disposable Urine Bag by Zhengzhou Medcons Import&Export Trading 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 | 697818666MKS010W4 | Class I | Active |
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Manufacturer
- Manufacturer
- Zhengzhou Medcons Import&Export Trading Co., Ltd
- EUDAMED SRN
- CN-MF-000045994
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 3d2c0ab8-7b7e-4d3a-94b0-17ba3b340340 61 fields · synced Jun 18, 2026