Identity
- Trade Name
- read on EUDAMEDFDA UDI
- Generic Name
- Prescription spectacles FDA UDI
- Device Name
- read on EUDAMED"3 mm eyewear & hard case, purple, +2.0 dpt, 1 unit in paper box incl. leaflet " FDA UDI
- Model / Reference
- 07640288790571 EUDAMED7640288790571 FDA UDI
- Description
- "3 mm eyewear & hard case, purple, +2.0 dpt, 1 unit in paper box incl. leaflet " FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640288790571 EUDAMEDFDA UDI
- Basic UDI-DI
- 764028879readonR9 EUDAMED
- Direct Marketing DI
- 07640288790571 EUDAMED
- FDA Product Code
- HOI FDA UDI
- EMDN Code
- Q0210030102 READY TO WEAR PLASTIC SPECTACLES WITH ORGANIC LENSES EUDAMED
- GMDN Term
- Prescription spectacles FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.5840 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
read on by read on GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764028879readonR9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- read on GmbH
- EUDAMED SRN
- CH-MF-000036836
- Authorised Representative
- MED-RAS GmbH Regulatory Affairs Service DE-AR-000006211
Sources (2)
- EUDAMED d832f69e-14af-43a3-b342-d9b4d944275c 61 fields · synced Jun 20, 2026
- FDA UDI 77dfd992-dbbe-4079-84c2-c0e131808c5f 33 fields · synced May 30, 2026