Identity
- Trade Name
- Urine Drainage Bag EUDAMED
- Device Name
- Urine Drainage Bag EUDAMED
- Model / Reference
- HUB 6007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970908500091 EUDAMED
- Basic UDI-DI
- 6970908506006AE EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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 Drainage Bag by Hoshin Medical 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 | 6970908506006AE | Class I | Active |
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Manufacturer
- Manufacturer
- Hoshin Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000003898
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 6493b305-f5d6-402c-9085-9f2d21660fea 61 fields · synced Jun 18, 2026