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Biosafe®
EUDAMEDClass IIa (EU MDR)
Ref 78221893Ref 78221897Ref 78221891Ref 78221900Ref 78221894Ref 78221896Ref 78221898Ref 78221895
Identity
- Trade Name
- BIOSAFE® EUDAMED
- Device Name
- BIOSAFE® 600 MD-smart (100) EUDAMEDBIOSAFE® 1400 MD-smart (230) EUDAMEDBIOSAFE® 600 MD-smart (230) EUDAMEDBIOSAFE® 2400 MD-smart (230) EUDAMEDBIOSAFE® 1000 MD-smart (230) EUDAMEDBIOSAFE® 1000 MD-smart (100) EUDAMEDBIOSAFE® 1400 MD-smart (120) EUDAMEDBIOSAFE® 1000 MD-smart (120) EUDAMED
- Model / Reference
- 78221893 EUDAMED78221897 EUDAMED78221891 EUDAMED78221900 EUDAMED78221894 EUDAMED78221896 EUDAMED78221898 EUDAMED78221895 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04252016600149 EUDAMED04252016600217 EUDAMED04252016600125 EUDAMED04252016600248 EUDAMED04252016600187 EUDAMED04252016600200 EUDAMED04252016600224 EUDAMED04252016600194 EUDAMED
- Basic UDI-DI
- B-04252016600149 EUDAMEDB-04252016600217 EUDAMEDB-04252016600125 EUDAMEDB-04252016600248 EUDAMEDB-04252016600187 EUDAMEDB-04252016600200 EUDAMEDB-04252016600224 EUDAMEDB-04252016600194 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Instrument transport trolley system.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04252016600149 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cryotherm GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000018064
Sources (8)
- EUDAMED 375fac44-d137-4d42-aefd-8af9fcc43451 61 fields · synced Jul 30, 2026
- EUDAMED 3f9c3a7c-5fd5-452e-a461-fdce75d1053d 61 fields · synced May 17, 2026
- EUDAMED 30545307-3c0e-4167-8168-5c9369b73b8d 61 fields · synced May 17, 2026
- EUDAMED 629e0213-f2ca-48b0-a5a8-fc98d8a5b758 61 fields · synced May 17, 2026
- EUDAMED 12fb8959-37ee-44ba-8a3c-225790b5f3d2 61 fields · synced May 18, 2026
- EUDAMED 20897364-185f-4346-8ec6-754e498864ba 61 fields · synced May 18, 2026
- EUDAMED 2e47330a-9bd7-445a-908a-fcc2c7f97632 61 fields · synced May 18, 2026
- EUDAMED 760703b0-e10c-4a06-a332-6cb078d85afb 61 fields · synced May 18, 2026