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hGH (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320509601Model 50T Ref 0320509604Model 2×100TRef 0320509603Model 100 T
Identity
- Trade Name
- hGH (eCLIA) EUDAMED
- Device Name
- hGH (eCLIA) EUDAMED
- Model / Reference
- 50T EUDAMED0320509601 EUDAMED2×100T EUDAMED0320509604 EUDAMED100 T EUDAMED0320509603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984064093 EUDAMED06975984064123 EUDAMED06975984064116 EUDAMED
- Basic UDI-DI
- B-06975984064093 EUDAMEDB-06975984064123 EUDAMEDB-06975984064116 EUDAMED
- EMDN Code
- W0102060402 HUMAN GROWTH HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
hGH (eCLIA) by Shenzhen Lifotronic Technology Co., 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-06975984064093 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED cfe96a5d-3f1e-4c17-afa3-d274a1b5e6e8 61 fields · synced Jul 19, 2026
- EUDAMED d1a678f7-a459-4707-8a0c-46febb1a2fe8 61 fields · synced May 18, 2026
- EUDAMED 04729d1b-119f-4da1-8267-c8ad23b9b329 61 fields · synced May 18, 2026