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Urine bag
EUDAMEDClass I (EU MDR)
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Identity
- Device Name
- Urine bag EUDAMED
- Model / Reference
- 2600ml EUDAMED1500ml EUDAMED500ml EUDAMED750ml EUDAMED350ml EUDAMED5000ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975498580041 EUDAMED06975498580027 EUDAMED06975498583851 EUDAMED06975498587736 EUDAMED06975498584476 EUDAMED06975498580058 EUDAMED
- Basic UDI-DI
- 697549858000019Z EUDAMED
- EMDN Code
- W05010203 URINE COLLECTION, CONTAINERS 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
Urine bag by K-Med 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 | 697549858000019Z | Class I | Active |
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Manufacturer
- Manufacturer
- K-Med Co., Ltd
- EUDAMED SRN
- CN-MF-000024689
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (6)
- EUDAMED 46ea3c59-6327-4d46-ad70-9ef6152f7a82 61 fields · synced Oct 6, 2026
- EUDAMED 469996a1-667d-4c77-a978-dab5997be5fc 61 fields · synced May 17, 2026
- EUDAMED 73fd69bd-ed99-417d-bfe4-0a4830dbcd57 61 fields · synced May 19, 2026
- EUDAMED b417e362-68b6-467a-89fe-5edfd7324d2a 61 fields · synced May 19, 2026
- EUDAMED 30c63f87-a32a-422a-a8ca-426aeccd6052 61 fields · synced May 19, 2026
- EUDAMED ae0a3e3e-5899-4936-87bd-a54dd25c6ce0 61 fields · synced May 19, 2026