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Sample Pretreatment Solution
EUDAMEDClass A (EU MDR)
Ref 01.09.63.02.01.05Ref 01.09.63.02.01.06
by Zybio Inc.
Identity
- Device Name
- Sample Pretreatment Solution EUDAMED
- Model / Reference
- 01.09.63.02.01.05 EUDAMED01.09.63.02.01.06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973262869149 EUDAMED06973262869187 EUDAMED
- Basic UDI-DI
- 69732628600032ZK EUDAMED
- EMDN Code
- W010499 MICROBIOLOGY TESTS - OTHER 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
Sample Pretreatment Solution 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 | 69732628600032ZK | 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 (2)
- EUDAMED 722eaef9-dabf-429b-889e-c557cc1f5a05 61 fields · synced Jul 26, 2026
- EUDAMED 11bfc1af-603d-4764-8667-ab9ffe284e7b 61 fields · synced May 17, 2026