Identity
- Trade Name
- Prime 810 EUDAMED
- Device Name
- Prime EUDAMED
- Model / Reference
- 810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649995521065 EUDAMED
- Basic UDI-DI
- 7649995521Laser74 EUDAMED
- EMDN Code
- Z12120202 LASER PHOTOCOAGULATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Cyprus 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
Prime 810 by Top Engineering Sarl — 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 | 7649995521Laser74 | Class I | Active |
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Manufacturer
- Manufacturer
- Top Engineering Sarl
- EUDAMED SRN
- CH-MF-000027119
- Authorised Representative
- QS MEDICAL DEVICE REGISTRATION LTD CY-AR-000024665
Sources (1)
- EUDAMED 302e6cac-99ab-4369-9840-07d1b8a4d501 61 fields · synced Jul 13, 2026