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Bracket Positioning Gauge .018", Anodized Aluminium
EUDAMEDClass I (EU MDR)
Ref D-134-219Model Bracket Positioning Instrument
Identity
- Trade Name
- BRACKET POSITIONING GAUGE .018", ANODIZED ALUMINIUM EUDAMED
- Device Name
- BRACKET POSITIONING GAUGE .018", ANODIZED ALUMINIUM EUDAMED
- Model / Reference
- Bracket Positioning Instrument EUDAMEDD-134-219 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961104042827 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
Bracket Positioning Gauge .018", Anodized Aluminium 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 3aa129b8-8a7b-491b-9072-a5a0dde59ec3 61 fields · synced Jun 18, 2026