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Multi Control
EUDAMEDClass IVD General (EU MDR)
Ref ZK904Y1Model 1×5mLRef ZK904Y2
Identity
- Trade Name
- Multi Control EUDAMED
- Device Name
- Multi Control EUDAMED
- Model / Reference
- 1×5mL EUDAMEDZK904Y1 EUDAMEDZK904Y2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595751024 EUDAMED06936595751031 EUDAMED
- Basic UDI-DI
- B-06936595751024 EUDAMEDB-06936595751031 EUDAMED
- EMDN Code
- W0101050101 ASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Multi Control by Medicalsystem Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06936595751024 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 665f29b7-27b6-4879-921d-3e30a6d3cdcc 61 fields · synced Aug 1, 2026
- EUDAMED 84dd4836-7e3c-450b-b849-1969a863f211 61 fields · synced May 18, 2026