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Boone Universal Gauge
EUDAMEDClass I (EU MDR)
Ref D-134-222Model Bracket Positioning Instrument
Identity
- Trade Name
- BOONE UNIVERSAL GAUGE EUDAMED
- Device Name
- BRACKET POSITIONING GAUGE .018", ANODIZED ALUMINIUM EUDAMED
- Model / Reference
- Bracket Positioning Instrument EUDAMEDD-134-222 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961104042841 EUDAMED
- Basic UDI-DI
- 896110404BR/INSTCLASSILZ EUDAMED
- EMDN Code
- L15901102 DAM POSITIONING INSTRUMENTS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Boone Universal Gauge by Mark One Surgical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 896110404BR/INSTCLASSILZ | Class I | Active |
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Manufacturer
- Manufacturer
- Mark One Surgical
- EUDAMED SRN
- PK-MF-000031202
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED bd527b81-324f-4895-89c8-bd27da62043c 61 fields · synced Sep 18, 2026