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Evolution 613
EUDAMEDClass IIa (EU MDR)
Ref EVO-613Model LABS Series Cryostorage Systems
Identity
- Trade Name
- Evolution 613 EUDAMED
- Device Name
- LABS Series Cryostorage Systems EUDAMED
- Model / Reference
- LABS Series Cryostorage Systems EUDAMEDEVO-613 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850038669683 EUDAMED
- Basic UDI-DI
- 0850038669003VS EUDAMED
- Direct Marketing DI
- 00850038669683 EUDAMED
- EMDN Code
- W020702 CRYOGENICS / FROZEN EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Evolution 613 by IC Biomedical, LLC — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850038669003VS | Class IIa | Active |
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Manufacturer
- Manufacturer
- IC Biomedical, LLC
- EUDAMED SRN
- US-MF-000024845
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED 107580fe-c445-4985-b37b-d22f0bcf1db8 61 fields · synced Jul 17, 2026