Identity
- Trade Name
- RollensPlus Platinum Gray EUDAMED
- Device Name
- Rollens Post-mydriatic glass EUDAMED
- Model / Reference
- 70401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860012470037 EUDAMED
- Basic UDI-DI
- 0860012470070201VP EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
RollensPlus Platinum Gray by The Rollens Company — 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 | 0860012470070201VP | Class I | Active |
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Manufacturer
- Manufacturer
- The Rollens Company
- EUDAMED SRN
- US-MF-000045283
- Authorised Representative
- Comply Express Lda PT-AR-000004357
Sources (1)
- EUDAMED f9c98da4-a8fb-4bd7-b9e0-ec05412a24ef 61 fields · synced Jul 24, 2026