Identity
- Trade Name
- Gauge EUDAMED
- Device Name
- Orthopaedic Instrument EUDAMED
- Model / Reference
- IG12-L30S3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800045330931 EUDAMED
- Basic UDI-DI
- 88000453BEOTI001KA EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Gauge by ORTHOTECH Co., Ltd — 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 | 88000453BEOTI001KA | Class I | Active |
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Manufacturer
- Manufacturer
- ORTHOTECH Co., Ltd
- EUDAMED SRN
- KR-MF-000048890
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED 6300a4e6-b938-4b66-9bb7-b1700535dd61 61 fields · synced Jun 20, 2026