Identity
- Trade Name
- SPECULAR MICROSCOPE SP-1P FDA UDI
- Generic Name
- Eye anterior segment analyser FDA UDI
- Model / Reference
- SP-1P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04562123288315 FDA UDI
- FDA Product Code
- NQE FDA UDI
- GMDN Term
- Eye anterior segment analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Eye anterior segment analyser
Specular Microscope Sp-1p by Topcon Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eye anterior segment analyser.
- ANTERION — Heidelberg Engineering · Class II
- WaveLight — Alcon Laboratories, Inc. · Class III
- ANTERION — Heidelberg Engineering · Class II
- ANTERION — Heidelberg Engineering · Class II
- ANTERION — Heidelberg Engineering · Class II
- TOMOCAP — Heidelberg Engineering · Class II
- GALILEI — SIS AG, Surgical Instrument Systems · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Topcon Corp.
Sources (1)
- FDA UDI 1919c487-ec5d-481c-8f09-de28a4f38252 32 fields · synced Jun 8, 2026