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Revolution 415
EUDAMEDClass IIa (EU MDR)
Ref REV-415Model LABS Series Cryostorage Systems
Identity
- Trade Name
- Revolution 415 EUDAMED
- Device Name
- LABS Series Cryostorage Systems EUDAMED
- Model / Reference
- LABS Series Cryostorage Systems EUDAMEDREV-415 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850038669584 EUDAMED
- Basic UDI-DI
- 0850038669003VS EUDAMED
- Direct Marketing DI
- 00850038669584 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
Revolution 415 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 c3b8d5dc-84f8-4bc3-a51e-f67c97385c43 61 fields · synced Jun 19, 2026