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Anatolia Geneworks
EUDAMEDClass A (EU MDR)
Ref ABXEXS1
by Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Identity
- Trade Name
- Anatolia Geneworks EUDAMED
- Device Name
- Bosphore STD EX-Tract Kit EUDAMED
- Model / Reference
- ABXEXS1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680018949502 EUDAMED
- Basic UDI-DI
- 868001894EXKFSTSTD25032E EUDAMED
- Direct Marketing DI
- 08680018949502 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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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 | 868001894EXKFSTSTD25032E | Class A | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000022487
Sources (1)
- EUDAMED 21cbd91a-5cef-48df-8078-7aa80d1a9312 61 fields · synced Jun 17, 2026