Identity
- Trade Name
- GPT R1:6x44, R2:3x22 ml (ΗΙΤ) EUDAMED
- Device Name
- GPT R1:6x44, R2:3x22 ml (ΗΙΤ) EUDAMED
- Model / Reference
- 001554 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05213003191766 EUDAMED
- Basic UDI-DI
- B-05213003191766 EUDAMED
- EMDN Code
- W01010103 ALANINE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
GPT R1:6x44, R2:3x22 ml (ΗΙΤ) by Biotechnological Applications Ltd — 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-05213003191766 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biotechnological Applications Ltd
- EUDAMED SRN
- GR-MF-000033000
Sources (1)
- EUDAMED a09cde2c-dc7b-4b1c-b083-e425515d0aae 61 fields · synced Jul 9, 2026