Identity
- Trade Name
- SK THERMO 13 mm rund / round grob / coarse EUDAMED
- Device Name
- SK PODO, SK THERMO, GT PODO, GT SPECIAL EUDAMED
- Model / Reference
- 35664 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04027497097494 EUDAMED
- Basic UDI-DI
- 4027497113115WB EUDAMED
- Unit of Use DI
- 14027497097491 EUDAMED
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I 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: Cranial bur, single-use
SK THERMO 13 mm rund / round grob / coarse by LUKAS-ERZETT GmbH & Co.KG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Cranial bur, single-use.
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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 | 4027497113115WB | Class I | Active |
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Manufacturer
- Manufacturer
- LUKAS-ERZETT GmbH & Co.KG
- EUDAMED SRN
- DE-MF-000005344
Sources (1)
- EUDAMED 0740a06d-2707-433f-aa21-a8c1b62b064b 61 fields · synced Jun 18, 2026