Identity
- Device Name
- Frez EUDAMED
- Model / Reference
- Cutter EUDAMED40.0117.000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05908447055520 EUDAMED
- Basic UDI-DI
- 59084472NL013M4 EUDAMED
- EMDN Code
- L0916 ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Fluted surgical drill bit, reusable
Frez by ChM spółka z ograniczoną odpowiedzialnością — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 59084472NL013M4 | Class I | Active |
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Manufacturer
- Manufacturer
- ChM spółka z ograniczoną odpowiedzialnością
- EUDAMED SRN
- PL-MF-000002121
Sources (1)
- EUDAMED 674a98f7-89d1-4995-be30-d94eb95a796e 61 fields · synced Jun 20, 2026