Identity
- Trade Name
- Countersink HB Ø 2.2 – 2.6 EUDAMED
- Device Name
- Strumenti chirurgici riutilizzabili accessori alle Viti per Osteosintesi EUDAMED
- Model / Reference
- STOI22200XK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053782780167 EUDAMED
- Basic UDI-DI
- 805771755FT08C1BZ EUDAMED
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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: Surgical implant template, reusable
Countersink HB Ø 2.2 – 2.6 by BRM Extremities S.r.l. — 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 | 805771755FT08C1BZ | Class I | Active |
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Manufacturer
- Manufacturer
- BRM Extremities S.r.l.
- EUDAMED SRN
- IT-MF-000016087
Sources (1)
- EUDAMED a8095e53-6faa-4f23-8777-922eed85fd4c 61 fields · synced Jul 30, 2026