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Reading glasses
EUDAMEDFDA UDIClass I (EU MDR)
Ref (+3.50 reading glasses)/227418Model SRP1278
Identity
- Trade Name
- Reading Glasses FDA UDI
- Generic Name
- Prescription spectacles FDA UDI
- Device Name
- Reading glasses EUDAMED
- Model / Reference
- SRP1278 EUDAMED(+3.50 reading glasses)/227418 EUDAMED6277BLK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973541151811 EUDAMED26973541154342 FDA UDI
- Basic UDI-DI
- 697354115PC-1228-BNTA EUDAMED
- FDA Product Code
- HOI FDA UDI
- EMDN Code
- Y210330 MAGNIFYING ACHROMATIC DOUBLET LENSES EUDAMED
- GMDN Term
- Prescription spectacles FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.5840 FDA UDI
- Market of Registration
- Netherlands 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
Reading glasses by Taizhou YuanMing Glasses Co., Ltd — 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 | 697354115PC-1228-BNTA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Taizhou Yuanming Glasses Co., Ltd
- EUDAMED SRN
- CN-MF-000001356
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 5f5e5133-9489-4ecf-868c-70359bc53f30 61 fields · synced Jul 17, 2026
- FDA UDI fba1ae09-05b6-46d8-ac1b-2fa493f657ce 32 fields · synced May 26, 2026