Identity
- Device Name
- plasmatherm EUDAMED
- Model / Reference
- 00010331 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04059201002043 EUDAMED
- Basic UDI-DI
- 4059201plasmathermTJ EUDAMED
- Direct Marketing DI
- 04059201002043 EUDAMED
- EMDN Code
- Z12019009 THAWING UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
plasmatherm by Barkey GmbH & Co. KG — 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 | 4059201plasmathermTJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Barkey GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005854
Sources (1)
- EUDAMED 5d162413-693b-4406-b483-1064c637dacb 61 fields · synced May 22, 2026