Identity
- Trade Name
- Sterile Bile Bags EUDAMED
- Device Name
- Sterile Bile Bags EUDAMED
- Model / Reference
- KB350ml EUDAMEDKB900ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955053702422 EUDAMED
- Basic UDI-DI
- 695505370245KB350mlJM EUDAMED
- Direct Marketing DI
- 06955053702422 EUDAMED
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER 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
Category: General-purpose suction system, pneumatic
Sterile Bile Bags by Vitaimed Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 695505370245KB350mlJM | 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 a0a2cf48-c759-4bb2-a694-79b6cc3b38b1 61 fields · synced Jun 18, 2026