Identity
- Trade Name
- Gelpi Loktite Retractor 13cm EUDAMED
- Device Name
- Gelpi Loktite Retractor 13cm EUDAMED
- Model / Reference
- 19.0180.13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003618872 EUDAMED
- Basic UDI-DI
- 896400361889640036188729Y EUDAMED
- EMDN Code
- L03140105 SKIN RETRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Gelpi Loktite Retractor 13cm by Crimson International — 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 | 896400361889640036188729Y | Class I | Active |
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Manufacturer
- Manufacturer
- Crimson International
- EUDAMED SRN
- PK-MF-000035275
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED da741125-b5cc-4621-9429-d6a5d3343f57 61 fields · synced Jul 21, 2026