Identity
- Device Name
- Barkey S-line EUDAMED
- Model / Reference
- 00011157 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04059201002982 EUDAMED
- Basic UDI-DI
- 4059201S-lineXX EUDAMED
- Direct Marketing DI
- 04059201002982 EUDAMED
- EMDN Code
- Z12019008 BLOOD HEATERS EUDAMED
Classification
- Device Class
- Class IIa 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
Barkey S-line by Barkey GmbH & Co. KG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213191 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4059201S-lineXX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Barkey GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005854
Sources (2)
- EUDAMED 28f60eea-650a-4fe3-84b4-ad54d5260364 61 fields · synced Oct 5, 2026
- FDA 510(k) K213191 1 fields · synced May 18, 2026