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Auto Lensmeter Lm-1800p
EUDAMEDFDA UDIClass I (EU MDR)
Ref 31029-0140Model LM-1800P,LM-1800PD,LM-7,LM7P
Identity
- Trade Name
- AUTO LENSMETER LM-1800P EUDAMEDAUTO LENSMETER FDA UDI
- Generic Name
- Manually-adjusted lensmeter, line-powered FDA UDI
- Device Name
- The NIDEK AUTO LENSMETER LM-1800P/LM-1800PD measures the optical performance of spectacle lenses such as single vision, bifocal (trifocal), and progressive power lenses or contact lenses. This device has a measuring unit and a display unit in front, and a printer unit on the right side. FDA UDI
- Model / Reference
- LM-1800P,LM-1800PD,LM-7,LM7P EUDAMED31029-0140 EUDAMEDLM-1800P FDA UDI
- Description
- The NIDEK AUTO LENSMETER LM-1800P/LM-1800PD measures the optical performance of spectacle lenses such as single vision, bifocal (trifocal), and progressive power lenses or contact lenses. This device has a measuring unit and a display unit in front, and a printer unit on the right side. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100622 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669106G7 EUDAMED
- FDA Product Code
- HLM FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Manually-adjusted lensmeter, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1425 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Auto Lensmeter Lm-1800p by Nidek 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 | 4987669106G7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NIDEK.CO.Ltd.,
- EUDAMED SRN
- JP-MF-000040151
- Authorised Representative
- NIDEK SA FR-AR-000000341
Sources (2)
- EUDAMED 607a0152-8e73-478c-8595-f2cf6be58b6b 61 fields · synced Jul 14, 2026
- FDA UDI 2b7b3e3d-c679-418e-bb6f-e59040f0940a 34 fields · synced May 30, 2026