Identity
- Trade Name
- QuickFit® Lacer, SM EUDAMED
- Device Name
- QuickFit Lacer Kits EUDAMED
- Model / Reference
- OK0200-130-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850028855492 EUDAMED
- Basic UDI-DI
- 0850028855OK0180130AC EUDAMED
- EMDN Code
- Y061280 LOWER LIMB ORTHOSES - ACCESSORIES 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
QuickFit® Lacer, SM by Click Medical LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: QuickFit Lacer
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 | 0850028855OK0180130AC | Class I | Active |
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Manufacturer
- Manufacturer
- Click Medical LLC
- EUDAMED SRN
- US-MF-000031805
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED e7b2fe9d-c314-4d3f-b8ee-1c14fad3d1a4 61 fields · synced Jul 18, 2026