Identity
- Trade Name
- Blackout Sphere Lens EUDAMED
- Device Name
- Jackson Handheld Cross Cylinder 1.00D EUDAMED
- Model / Reference
- 7023 EUDAMED7030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811286036719 EUDAMED
- Basic UDI-DI
- 081128603PVInTLens96 EUDAMED
- Direct Marketing DI
- 00811286036719 EUDAMED
- EMDN Code
- Q0210010299 MINERAL OPHTHALMIC 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
Blackout Sphere Lens 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 | 081128603PVInTLens96 | 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 b2b89a14-dd07-42ef-bb2e-e643a0ae7365 61 fields · synced Aug 1, 2026