Identity
- Trade Name
- BIOSAFE® EUDAMEDBIOSAFE® 500 MD-smart (230 Volt) EUDAMED
- Device Name
- BIOSAFE® 500 MD-smart (230) EUDAMEDBIOSAFE®MD EUDAMED
- Model / Reference
- 78221888 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04252016600095 EUDAMED
- Basic UDI-DI
- B-04252016600095 EUDAMED42520166BIOSAFE-MDD2 EUDAMED
- Direct Marketing DI
- 04252016600095 EUDAMED
- EMDN Code
- V0499 CLINICAL USE CONTAINERS (NON-IVD) - OTHER 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
Category: Instrument transport trolley system
Biosafe® by Cryotherm GmbH & Co. KG — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04252016600095 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04252016600095 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cryotherm GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000018064
Sources (2)
- EUDAMED fe6b4932-d8d8-426a-b35b-8210f0a00252 61 fields · synced Aug 4, 2026
- EUDAMED 509bda92-ab63-43c5-bd47-24f260c6c2c1 61 fields · synced May 18, 2026