Identity
- Trade Name
- Guide EUDAMED
- Device Name
- Orthopaedic Instrument EUDAMED
- Model / Reference
- IS20-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800045325739 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
The Guide medical device is a Class I orthopedic instrument designed for precise placement of orthopaedic sutures. It features a sterile design, ensuring the sterility and safety of patients. With its advanced technology and ergonomic design, the Guide provides accurate and reliable suturing capabilities.
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 0e5cbc7d-a7f6-42a4-9ca0-37dee736cbf1 61 fields · synced Jul 13, 2026