Identity
- Trade Name
- Surgify Safety Burr EUDAMED
- Device Name
- Surgify Safety Burr EUDAMED
- Model / Reference
- 100-54-TM EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-100-54-TMHE EUDAMED
- Basic UDI-DI
- B-100-54-TMHE EUDAMED
- EMDN Code
- V0199,Z12100985,Z12130585,Z12149085 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
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
Surgify Safety Burr by Surgify Medical Oy — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-100-54-TMHE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Surgify Medical Oy
- EUDAMED SRN
- FI-MF-000017137
Sources (1)
- EUDAMED 9354ff6e-9910-428d-a5a2-a542683666d6 61 fields · synced Jun 19, 2026