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Frez
EUDAMEDClass I (EU MDR)
Ref 40.5897.100Model CutterRef 40.0116.000Ref 40.0555.000Ref 40.0557.000Ref 40.0111.000Ref 40.0114.000Ref 40.0554.000Ref 40.0553.000Ref 40.0551.000Ref 40.0112.000Ref 40.6810.200
Identity
- Device Name
- Frez EUDAMED
- Model / Reference
- Cutter EUDAMED40.5897.100 EUDAMED40.0116.000 EUDAMED40.0555.000 EUDAMED40.0557.000 EUDAMED40.0111.000 EUDAMED40.0114.000 EUDAMED40.0554.000 EUDAMED40.0553.000 EUDAMED40.0551.000 EUDAMED40.0112.000 EUDAMED40.6810.200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05908447702981 EUDAMED05908447055506 EUDAMED05908447062948 EUDAMED05908447062986 EUDAMED05908447055407 EUDAMED05908447055469 EUDAMED05908447062924 EUDAMED05908447062900 EUDAMED05908447062863 EUDAMED05908447055421 EUDAMED05908447710818 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 (11)
- EUDAMED 1ac90272-c29d-4996-a4cb-332b6f8a5628 61 fields · synced Jul 30, 2026
- EUDAMED 6686285c-9b32-4b22-80ca-12f4246b2a8b 61 fields · synced May 17, 2026
- EUDAMED b1a7a185-6468-4ecf-9070-5b446b2d23a7 61 fields · synced May 17, 2026
- EUDAMED 550ea75d-6719-4ecc-b77e-41f449b4cca7 61 fields · synced May 17, 2026
- EUDAMED 2018b3b1-d4de-42b2-8462-328f296c69f0 61 fields · synced May 17, 2026
- EUDAMED 7451a034-4a38-4a49-9e57-e529475c8f39 61 fields · synced May 17, 2026
- EUDAMED d4eac237-14ef-4be8-b1b2-a75abadaa009 61 fields · synced May 17, 2026
- EUDAMED 972d483a-ae38-4e3e-b525-7be436f0c90d 61 fields · synced May 18, 2026
- EUDAMED e585a3a9-7ddb-48ef-a53c-27f67a8fb868 61 fields · synced May 18, 2026
- EUDAMED 63cb7668-c30c-49fa-a9ab-0d64686ed1f8 61 fields · synced May 18, 2026
- EUDAMED 543be6b8-a9a9-431f-a194-824d4e442033 61 fields · synced May 18, 2026