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HGH CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CML0202Model AutoLumo AnalyzerRef CML0201Ref CML0203Ref CML0205
Identity
- Trade Name
- HGH CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo Analyzer EUDAMEDCML0202 EUDAMEDCML0201 EUDAMEDCML0203 EUDAMEDCML0205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150908911 EUDAMED06975577171320 EUDAMED06942359550994 EUDAMED06942359551014 EUDAMED
- Basic UDI-DI
- 697015090000040GU EUDAMED
- EMDN Code
- W0102060402 HUMAN GROWTH HORMONE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMEDGreece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
New Device
No
EUDAMED
HGH CLIA Microparticles by Autobio Diagnostics Co., Ltd. — Class B — 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 | 697015090000040GU | Class B | Active |
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Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (4)
- EUDAMED 09b2355f-a910-4207-84c4-a6f70ad34a33 61 fields · synced Aug 3, 2026
- EUDAMED 37f1e2c1-d3e0-4db8-b387-e39dd78afece 61 fields · synced May 18, 2026
- EUDAMED bd15e9f0-6fb0-4829-8a36-f212b80cfb74 61 fields · synced May 18, 2026
- EUDAMED 3ab74f5d-ec06-45fe-9275-17ce55c515a9 61 fields · synced May 18, 2026