Identity
- Trade Name
- Urine Bag EUDAMED
- Device Name
- Urine Bag(with straps) EUDAMED
- Model / Reference
- KYE01 EUDAMEDKYE01-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955053702040 EUDAMED
- Basic UDI-DI
- 695505370215KYE0158 EUDAMED
- Direct Marketing DI
- 06955053702040 EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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 Bag by Vitaimed Instrument 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 | 695505370215KYE0158 | Class I | Active |
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Manufacturer
- Manufacturer
- Vitaimed Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000033172
- Authorised Representative
- VITAIMED GmbH DE-AR-000029575
Sources (1)
- EUDAMED f6f4785e-82da-4af9-bae3-7f8d8deb198f 61 fields · synced Jun 18, 2026