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Concentrated Detergent
EUDAMEDClass A (EU MDR)
Ref 042304003Ref 042304002
by Zybio Inc.
Identity
- Device Name
- Concentrated Detergent EUDAMED
- Model / Reference
- 042304003 EUDAMED042304002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967227007 EUDAMED06941967225072 EUDAMED
- Basic UDI-DI
- 69732628600070ZT EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) 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
Concentrated Detergent 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 | 69732628600070ZT | 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 0e3dbe07-45cb-46ce-976a-9960e7931f96 61 fields · synced Jul 31, 2026
- EUDAMED 04248ae3-cba2-4190-b785-91f129c3da96 61 fields · synced May 18, 2026