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Lipase
EUDAMEDClass IVD General (EU MDR)
Ref B21226
by Bioanalytic Diagnostik Kimya Sanayi ve Ticaret Limited Şirketi
Identity
- Trade Name
- Lipase EUDAMED
- Device Name
- Lipase EUDAMED
- Model / Reference
- B21226 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681554402148 EUDAMED
- Basic UDI-DI
- B-08681554402148 EUDAMED
- EMDN Code
- W01010123 LIPASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Lipase by Bioanalytic Diagnostik Kimya Sanayi ve Ticaret Limited Şirketi — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08681554402148 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000034087
Sources (1)
- EUDAMED a09b84f0-90cb-471f-af2a-f4b9132935ec 61 fields · synced Oct 6, 2026