Identity
- Trade Name
- Nucleic Acid Extractor EUDAMED
- Device Name
- Nucleic Acid Extractor EUDAMED
- Model / Reference
- TS-32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975422630040 EUDAMED
- Basic UDI-DI
- 697542263TS-32K9 EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Nucleic Acid Extractor by TransGen 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 | 697542263TS-32K9 | Class A | Active |
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Manufacturer
- Manufacturer
- TransGen Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000025790
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED e017ff5c-8719-4186-bdf2-8019e405d293 61 fields · synced Jul 17, 2026