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Human Growth Hormone（GH）Detection Kit（Magnetic Solid Phase Chemiluminescent Imm…
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/kit（DR1113-2）Model 100 Tests/kitRef 200 Tests/kit（DR1113-3）Model 200 Tests/kitRef 50 Tests/kit（DR1113-1）Model 50 Tests/kit
Identity
- Trade Name
- Human Growth Hormone（GH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Human Growth Hormone（GH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED100 Tests/kit（DR1113-2） EUDAMED200 Tests/kit EUDAMED200 Tests/kit（DR1113-3） EUDAMED50 Tests/kit EUDAMED50 Tests/kit（DR1113-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969981998 EUDAMED06974969982568 EUDAMED06974969981424 EUDAMED
- Basic UDI-DI
- B-06974969981998 EUDAMEDB-06974969982568 EUDAMEDB-06974969981424 EUDAMED
- EMDN Code
- W0102060402 HUMAN GROWTH HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Human Growth Hormone（GH）Detection Kit（Magnetic Solid Phase Chemiluminescent Imm… by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class IVD General…
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-06974969981998 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (3)
- EUDAMED a8f6a40e-f55d-4ee0-8aaf-e4c56fae52c5 61 fields · synced Oct 6, 2026
- EUDAMED 93122633-f167-4c56-b38e-032026dc66ba 61 fields · synced May 19, 2026
- EUDAMED 16ce1ac9-9571-4660-837b-f6632249c7ab 61 fields · synced May 19, 2026