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Gauge
EUDAMEDClass I (EU MDR)
Ref IG42-02Ref IS15-08Ref IG41-01ARef IG12-L30S1Ref C0044Ref IG32-L80Ref IS14-08Ref IG41-01Ref IG01-26 Ref IP20-34
Identity
- Trade Name
- Gauge EUDAMED
- Device Name
- Orthopaedic Instrument EUDAMED
- Model / Reference
- IG42-02 EUDAMEDIS15-08 EUDAMEDIG41-01A EUDAMEDIG12-L30S1 EUDAMEDC0044 EUDAMEDIG32-L80 EUDAMEDIS14-08 EUDAMEDIG41-01 EUDAMEDIG01-26 EUDAMEDIP20-34 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800045326255 EUDAMED08800045325654 EUDAMED08800045324695 EUDAMED08800045330894 EUDAMED08800045323568 EUDAMED08800045330498 EUDAMED08800045325586 EUDAMED08800045330849 EUDAMED08800045324671 EUDAMED08800045325036 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 (10)
- EUDAMED c74590a3-e4b1-4174-b078-d1f5e4530840 61 fields · synced Aug 4, 2026
- EUDAMED 6354d635-0003-4f0b-85b7-2769bd6cd390 61 fields · synced May 17, 2026
- EUDAMED 0dae37a3-2ccd-4d5e-9474-350d7186dc24 61 fields · synced May 17, 2026
- EUDAMED 729b3613-e6a7-4f4e-89c3-03d86540ad62 61 fields · synced May 17, 2026
- EUDAMED f232deab-ca5a-4d57-9fca-256fc986bb95 61 fields · synced May 17, 2026
- EUDAMED 943d7384-72a1-4755-be56-facfb487419c 61 fields · synced May 18, 2026
- EUDAMED bf080979-b7e5-40ef-ae56-7d4148532916 61 fields · synced May 18, 2026
- EUDAMED 01751190-74d4-4a5a-b2f4-16bb58b68754 61 fields · synced May 18, 2026
- EUDAMED a964fbf8-8675-444a-9251-89827b4d884d 61 fields · synced May 18, 2026
- EUDAMED d9ce7816-e9ce-4f5f-bb5a-c80d893999ca 61 fields · synced May 18, 2026