Identity
- Trade Name
- BC Tip EXT EUDAMED
- Device Name
- BC Tip EXT, BC Tip 1000-R EUDAMED
- Model / Reference
- 995-05001, 991-05101 EUDAMED995-05001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14987481163864 EUDAMED
- Basic UDI-DI
- 49874811498748116386424 EUDAMED
- EMDN Code
- W0503020202 PIPETTES, TIPS WITHOUT FILTER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
BC Tip EXT by Fujifilm Wako Pure Chemical Corporation — 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 | 49874811498748116386424 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FUJIFILM Wako Pure Chemical Corporation
- EUDAMED SRN
- JP-MF-000013944
- Authorised Representative
- FUJIFILM Wako Chemicals Europe GmbH DE-AR-000011552
Sources (1)
- EUDAMED 41cce51a-d5fd-4bb5-a77f-082ee80c2f63 61 fields · synced Jun 18, 2026