Identity
- Trade Name
- Deluxe Comfort Clinical Trial Frame EUDAMED
- Device Name
- Premier Clinical Trial Frame EUDAMED
- Model / Reference
- 7025 EUDAMED7045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811286038287 EUDAMED
- Basic UDI-DI
- 081128603PVTFrameGW EUDAMED
- Direct Marketing DI
- 00811286038287 EUDAMED
- EMDN Code
- Q02100299 SPECTACLE FRAMES WITHOUT LENSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Deluxe Comfort Clinical Trial Frame by Precision Vision, Inc. — 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 | 081128603PVTFrameGW | Class I | Active |
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Manufacturer
- Manufacturer
- Precision Vision, Inc.
- EUDAMED SRN
- US-MF-000008456
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (1)
- EUDAMED 7ee38a26-91fe-4fff-ad9d-9a91129a2a0c 61 fields · synced Jun 18, 2026