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Human Growth Hormone Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013842Model 2×50 tests/kitRef 3010516Model 1×100 tests/kit
Identity
- Trade Name
- Human Growth Hormone Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Human Growth Hormone Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 2×50 tests/kit EUDAMED3013842 EUDAMED1×100 tests/kit EUDAMED3010516 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202224027 EUDAMED06925794517883 EUDAMED
- Basic UDI-DI
- B-06942202224027 EUDAMEDB-06925794517883 EUDAMED
- EMDN Code
- W0102060402 HUMAN GROWTH HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Human Growth Hormone Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06942202224027 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 5df5debb-bee0-4f27-a314-aa4f3cbd23bd 61 fields · synced Jul 23, 2026
- EUDAMED addb79ae-0c04-4f25-970f-57767f3215bf 61 fields · synced May 18, 2026