← Back to catalogue
Guide
EUDAMEDClass I (EU MDR)
Ref IG42-3346Ref IG41-16Ref IG42-38ARef IP20-14Ref IP20-11Ref C0001Ref IS14-06Ref IS15-06Ref IG41-29Ref IP20-13
Identity
- Trade Name
- Guide EUDAMED
- Device Name
- Orthopaedic Instrument EUDAMED
- Model / Reference
- IG42-3346 EUDAMEDIG41-16 EUDAMEDIG42-38A EUDAMEDIP20-14 EUDAMEDIP20-11 EUDAMEDC0001 EUDAMEDIS14-06 EUDAMEDIS15-06 EUDAMEDIG41-29 EUDAMEDIP20-13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800045326958 EUDAMED08800045324725 EUDAMED08800045330887 EUDAMED08800045303058 EUDAMED08800045303034 EUDAMED08800045323391 EUDAMED08800045325562 EUDAMED08800045325630 EUDAMED08800045324732 EUDAMED08800045303041 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
Guide 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ORTHOTECH Co., Ltd
- EUDAMED SRN
- KR-MF-000048890
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (10)
- EUDAMED 65e5eaad-0ebc-4a0e-8d26-af676f5fd2eb 61 fields · synced Aug 3, 2026
- EUDAMED 4b6907af-e4b0-405b-acb3-5b2adcbefdd9 61 fields · synced May 16, 2026
- EUDAMED 3fc8445e-b5ce-4702-a1b9-65946a2049a7 61 fields · synced May 17, 2026
- EUDAMED bb3af4bb-e290-4a1d-a7c6-796155b63eb5 61 fields · synced May 17, 2026
- EUDAMED 06adec2c-7712-46c4-8d91-68aef58e8cce 61 fields · synced May 17, 2026
- EUDAMED f4abebbb-d468-481b-a86e-fd92916b8ca2 61 fields · synced May 18, 2026
- EUDAMED 591c980b-204a-430c-b3e6-6f95af996db2 61 fields · synced May 18, 2026
- EUDAMED 2decd817-c358-4ca4-8bc8-77e468e3c5e5 61 fields · synced May 18, 2026
- EUDAMED e0494b06-0eb9-453b-8317-5ceaf4a299da 61 fields · synced May 18, 2026
- EUDAMED 270d99e2-00ef-4f4b-aabe-f2544e2fe02a 61 fields · synced May 19, 2026