← Back to catalogue
SK THERMO 5 mm rund / round grob / coarse
EUDAMEDClass I (EU MDR)
Ref A21080052080
Identity
- Trade Name
- SK THERMO 5 mm rund / round grob / coarse EUDAMED
- Device Name
- SK PODO, SK THERMO, GT PODO, GT SPECIAL EUDAMED
- Model / Reference
- A21080052080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04027497600311 EUDAMED
- Basic UDI-DI
- 4027497113115WB EUDAMED
- Unit of Use DI
- 14027497600318 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 5 mm rund / round grob / coarse by LUKAS-ERZETT GmbH & Co.KG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cranial bur, single-use.
- HiCUT Burs — adeor Medical AG · Class II
- Disposable Sterile Vessel Punch — Zibo MK Medical Technology Co., Ltd. · Class IIa
- PDS-2RDUL-15 — NAKANISHI INC. · Class IIa
- Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
- J-Notch Burs — Stryker Instruments · Class IIa
- Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
- PMT Drill Cutter — adeor Medical AG · Class II
- Einmal-Schere Metzenbaum, stumpf/stumpf, fein, gebogen, 11, 5 cm, unsteril — Fuhrmann GmbH · Class IIa
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LUKAS-ERZETT GmbH & Co.KG
- EUDAMED SRN
- DE-MF-000005344
Sources (1)
- EUDAMED 33bc4ab7-6837-4e4f-ae94-37a55bc2552a 61 fields · synced Jun 18, 2026