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ZymoBIOMICS 96 MagBead DNA Kit (Lysis Tubes)
EUDAMEDClass A (EU MDR)
Ref D4308-EModel D4302-E
Identity
- Trade Name
- ZymoBIOMICS 96 MagBead DNA Kit (Lysis Tubes) EUDAMED
- Device Name
- ZymoBIOMICS 96 MagBead DNA Kit (Lysis Rack) EUDAMED
- Model / Reference
- D4302-E EUDAMEDD4308-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850027600192 EUDAMED
- Basic UDI-DI
- 0850027600D4032B5 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
- France 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
Category: Nucleic acid extraction/isolation kit IVD
ZymoBIOMICS 96 MagBead DNA Kit (Lysis Tubes) by Zymo Research Corp. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0850027600D4032B5 | Class A | Active |
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Manufacturer
- Manufacturer
- Zymo Research Corp.
- EUDAMED SRN
- US-MF-000019308
- Authorised Representative
- DAVID Catherine Elisabeth Marie FR-AR-000006724
Sources (1)
- EUDAMED b25d3813-9140-488d-8e3b-5ce5c7fff682 61 fields · synced Jul 10, 2026