Identity
- Trade Name
- Sterile Bile Bags EUDAMED
- Device Name
- Sterile Bile Bags EUDAMED
- Model / Reference
- KB350ml EUDAMEDKB500ml EUDAMEDKB750ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955053702446 EUDAMED06955053702439 EUDAMED06955053702453 EUDAMED
- Basic UDI-DI
- 695505370245KB350mlJM EUDAMED
- Direct Marketing DI
- 06955053702446 EUDAMED06955053702439 EUDAMED06955053702453 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
Similar devices
Also classified as General-purpose suction system, pneumatic.
- Furine Collect — Furine ApS · Class I
- VarioAir D DIN — Drägerwerk AG & Co. KGaA · Class IIa
- Furine plus — Furine ApS · Class I
- VarioAir B/OP Schiene Diss — Drägerwerk AG & Co. KGaA · Class IIa
- Non-sterile aspiration tubes - Flexivac bags — Produtos Médicos Hospitalares, SA · Class I
- Furine — Furine ApS · Class I
- Non-sterile aspiration tubes - Flexivac bags — Produtos Médicos Hospitalares, SA · Class I
- VarioAir B BS — Drägerwerk AG & Co. KGaA · Class IIa
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vitaimed Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000033172
- Authorised Representative
- VITAIMED GmbH DE-AR-000029575
Sources (3)
- EUDAMED 3d9a0d98-5542-4452-9759-be7860f946b3 61 fields · synced Jul 22, 2026
- EUDAMED c6ddeea2-440a-446e-ab94-35d9acef5b62 61 fields · synced May 16, 2026
- EUDAMED 92f49e27-8d09-4886-aa8c-f6ea976c833a 61 fields · synced May 17, 2026