Identity
- Trade Name
- Class II Type B2 Biosafety Cabinet EUDAMED
- Device Name
- Biological Safety Cabinet EUDAMED
- Model / Reference
- BSC-IIB2-3J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975488440881 EUDAMED
- Basic UDI-DI
- 697548844BSC22PG EUDAMED
- EMDN Code
- W02070301 BIOLOGICAL HOODS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Class II Type B2 Biosafety Cabinet by Infitek 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 | 697548844BSC22PG | Class I | Active |
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Manufacturer
- Manufacturer
- Infitek Co., Ltd.
- EUDAMED SRN
- CN-MF-000040107
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED ce4bb6bb-facd-4b8e-b42b-fb089a397d9b 61 fields · synced Jun 18, 2026