Identity
- Trade Name
- PD METER PM-700 EUDAMEDPD Meter FDA UDI
- Generic Name
- Ophthalmodiastimeter FDA UDI
- Device Name
- The PD meter model PM-700 is a pupillary distance meter improved with a built-in computer and LCD digital display. FDA UDI
- Model / Reference
- PM-700 EUDAMEDFDA UDI35241-0040 EUDAMED
- Description
- The PD meter model PM-700 is a pupillary distance meter improved with a built-in computer and LCD digital display. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100837 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669109GD EUDAMED
- FDA Product Code
- HLG FDA UDI
- EMDN Code
- V030203 OPHTHALMOLOGY MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Ophthalmodiastimeter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1700 FDA UDI
- Market of Registration
- Cyprus 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
Pd Meter Pm-700 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 | 4987669109GD | 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 0e799cdb-6e28-4a6e-8194-d95c63dee80b 61 fields · synced Jun 17, 2026
- FDA UDI 2b0c9add-a9ee-4864-b5b3-7f2a46903952 34 fields · synced May 30, 2026