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Anatolia Geneworks
EUDAMEDClass A (EU MDR)
Ref UM32V1
by Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Identity
- Trade Name
- Anatolia Geneworks EUDAMED
- Device Name
- Unio M32 Viral DNA/RNA Extraction Kit EUDAMED
- Model / Reference
- UM32V1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684198020822 EUDAMED
- Basic UDI-DI
- 868001894EXKUM32V1V2 EUDAMED
- Direct Marketing DI
- 08684198020822 EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
No
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Anatolia Geneworks by Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S. — Class A — IVDR — listed in EUDAMED
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 868001894EXKUM32V1V2 | Class A | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000022487
Sources (1)
- EUDAMED e525833e-a013-4b8d-b443-bd2e100c3e55 61 fields · synced Jun 19, 2026