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Nucleic Acid Extraction Kit (Magnetic Bead Method)
EUDAMEDClass A (EU MDR)
Ref 01.09.20.00.B2.08Ref 01.09.20.00.B2.17 Ref 01.09.20.00.T1.07 Ref 01.09.20.00.B2.12 Ref 01.09.20.08.B2.11Ref 01.09.20.08.B2.09Ref 01.09.20.08.B2.08
by Zybio Inc.
Identity
- Trade Name
- Nucleic Acid Extraction Kit (Magnetic Bead Method) EUDAMED
- Device Name
- Nucleic Acid Extraction Kit (Magnetic Bead Method) EUDAMED
- Model / Reference
- 01.09.20.00.B2.08 EUDAMED01.09.20.00.B2.17 EUDAMED01.09.20.00.T1.07 EUDAMED01.09.20.00.B2.12 EUDAMED01.09.20.08.B2.11 EUDAMED01.09.20.08.B2.09 EUDAMED01.09.20.08.B2.08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973262865783 EUDAMED06973262866223 EUDAMED06973262860139 EUDAMED06973262866247 EUDAMED06973262866070 EUDAMED06973262866056 EUDAMED06973262866049 EUDAMED
- Basic UDI-DI
- 69732628600015ZK EUDAMED69732628600014ZH 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 EUDAMEDItaly 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 | 69732628600015ZK | 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 (7)
- EUDAMED 1908655a-be49-4628-a653-45e559df88dd 61 fields · synced Aug 4, 2026
- EUDAMED 34e6358d-e5a5-4a1f-873a-408bd5303cd2 61 fields · synced May 17, 2026
- EUDAMED 8b871c15-2d7a-4c85-991c-c7ff04dea075 61 fields · synced May 17, 2026
- EUDAMED fcf55e7d-c5ae-40ec-84b7-97bc4719e065 61 fields · synced May 17, 2026
- EUDAMED f4b118eb-5054-402e-b818-9a29357ecc44 61 fields · synced May 17, 2026
- EUDAMED 1c52c1bc-6f98-400e-a048-c8bae75ba624 61 fields · synced May 18, 2026
- EUDAMED 45eb9423-c6ce-4611-9e0f-5d2736c89fa6 61 fields · synced May 19, 2026