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BITRAN® BAG 6 INCH x 6 INCH (150x150mm)
EUDAMEDClass A (EU MDR)
Ref WAA-0300-12A
by CellPath Ltd
Identity
- Trade Name
- BITRAN® BAG 6 INCH x 6 INCH (150x150mm) EUDAMED
- Device Name
- BITRAN® BAG EUDAMED
- Model / Reference
- WAA-0300-12A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060470567750 EUDAMED
- Basic UDI-DI
- 05060470WAA001YB EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
BITRAN® BAG 6 INCH x 6 INCH (150x150mm) by CellPath Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 05060470WAA001YB | Class A | Active |
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Manufacturer
- Manufacturer
- CellPath Ltd
- EUDAMED SRN
- GB-MF-000022744
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED cbf5ef9c-b1f7-419c-8d34-0b2c741291f6 61 fields · synced Jul 12, 2026