Identity
- Trade Name
- Perimeter FDA UDI
- Generic Name
- Perimeter, automatic FDA UDI
- Device Name
- It is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light. FDA UDI
- Model / Reference
- SK-850A FDA UDI
- Description
- It is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973211070534 FDA UDI
- FDA Product Code
- HPT FDA UDI
- GMDN Term
- Perimeter, automatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1605 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Perimeter, automatic
Perimeter by Chongqing Sunkingdom Medical Instrument Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Perimeter, automatic.
- VisuALL VRP S — Olleyes, Inc. · Class I
- Medmont Automated Perimeter M700 USB — MEDMONT INTERNATIONAL PTY LTD · Class I
- PalmScan VF2000 — MICRO MEDICAL DEVICES, INC. · Class I
- COMPASS — CENTERVUE S.P.A. · Class IIa
- Virtual Eye Software — VIRTUAL VISION HEALTH · Class I
- Virtual Field — Field Virtual Inc · Class I
- VisionOne — PeriVision SA · Class I
- Twinfield 3 — OCULUS Optikgeräte GmbH · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Chongqing Sunkingdom Medical Instrument Co., Ltd
Sources (1)
- FDA UDI e33de0d3-815e-4aff-82c1-4cafa5ba0620 33 fields · synced May 30, 2026