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Nucleic Acid Extraction Kit (Magnetic Bead Method)
EUDAMEDClass A (EU MDR)
Ref 01.09.20.08.T1.11
by Zybio Inc.
Identity
- Device Name
- Nucleic Acid Extraction Kit (Magnetic Bead Method) EUDAMED
- Model / Reference
- 01.09.20.08.T1.11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973262861303 EUDAMED
- Basic UDI-DI
- 69732628600014ZH 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
- Netherlands 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
Nucleic Acid Extraction Kit (Magnetic Bead Method) by Zybio Inc. — 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 | 69732628600014ZH | Class A | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 7f0ec4e1-4244-4fa2-8b3f-d6e57788874c 61 fields · synced Jun 19, 2026