Identity
- Device Name
- Automatic Nucleic Acid Extraction Instrument EUDAMED
- Model / Reference
- H24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974591041145 EUDAMED
- Basic UDI-DI
- 6974591041006B2 EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
Automatic Nucleic Acid Extraction Instrument by Creative Biosciences (Guangzhou) 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 | 6974591041006B2 | Class A | Active |
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Manufacturer
- Manufacturer
- Creative Biosciences (Guangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000034058
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 2bf932ac-14ff-4433-b62e-aafda589c989 61 fields · synced Jul 9, 2026