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Universal DNA Library Prep Kit
EUDAMEDClass A (EU MDR)
Ref ZD101-02(96rxns)Model ZD101-01(24rxns)、ZD101-02(96rxns)、ZDM101-01(24rxns)、ZDM101-02(96rxns)Ref ZDM101-01(24rxns)Ref ZDM101-02(96rxns)Ref ZD101-01(24rxns)
Identity
- Device Name
- Universal DNA Library Prep Kit EUDAMED
- Model / Reference
- ZD101-01(24rxns)、ZD101-02(96rxns)、ZDM101-01(24rxns)、ZDM101-02(96rxns) EUDAMEDZD101-02(96rxns) EUDAMEDZDM101-01(24rxns) EUDAMEDZDM101-02(96rxns) EUDAMEDZD101-01(24rxns) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975516220089 EUDAMED06975516220096 EUDAMED06975516220102 EUDAMED06975516220072 EUDAMED
- Basic UDI-DI
- 697551622ZXUDLPKJ9 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Iceland EUDAMEDAustria EUDAMEDSpain 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
Universal DNA Library Prep Kit by Xiamen Zhixuan Biotech Co., Ltd — 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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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 | 697551622ZXUDLPKJ9 | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Zhixuan Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000027993
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 48348b79-7006-44de-bc54-5e62146737c5 61 fields · synced Aug 3, 2026
- EUDAMED 90ce206b-9db5-4ff3-a793-386397ab69e0 61 fields · synced May 17, 2026
- EUDAMED dabcf783-c5e0-4c9c-9e83-484877e515b5 61 fields · synced May 18, 2026
- EUDAMED 25295818-91f7-495f-bab7-a71135989dcd 61 fields · synced May 19, 2026