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Protein Extraction Kit
EUDAMEDClass A (EU MDR)
Ref HGOTHER09Model Please see the IFU
Identity
- Trade Name
- Protein Extraction Kit EUDAMED
- Device Name
- Protein Extraction Kit EUDAMED
- Model / Reference
- Please see the IFU EUDAMEDHGOTHER09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936700409567 EUDAMED
- Basic UDI-DI
- 697029753473LZ EUDAMED
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A 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
New Device
No
EUDAMED
Protein Extraction Kit by Beijing Hotgen Biotech Co., Ltd. — Class A — 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 | 697029753473LZ | Class A | Active |
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Manufacturer
- Manufacturer
- Beijing Hotgen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000015566
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 9710a949-c07b-401b-b967-52854dc1e38e 61 fields · synced Jul 31, 2026