Identity
- Trade Name
- Corneal Topographer FDA UDI
- Generic Name
- Corneal topography system analyser FDA UDI
- Model / Reference
- SK-7000A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973211071623 FDA UDI
- FDA Product Code
- MMQ FDA UDI
- GMDN Term
- Corneal topography system analyser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1350 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: Corneal topography system analyser
Corneal Topographer by Chongqing Sunkingdom Medical Instrument Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Corneal topography system analyser.
- TearCheck T — E-Swin · Class I
- WAVE ANALYZER MEDICA 800 — ESSILOR INTERNATIONAL · Class II
- ALADDIN TMS — VISIA IMAGING SRL · Class II
- SeeNA — VISIA IMAGING SRL · Class II
- MOPTIM — Shenzhen CERTAINN Technology Co., Ltd. · Class I
- ALADDIN HW3.0 — VISIA IMAGING SRL · Class II
- ALADDIN-M — VISIA IMAGING SRL · Class II
- WAVE ANALYZER MEDICA 700 PLUS — ESSILOR INTERNATIONAL · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chongqing Sunkingdom Medical Instrument Co., Ltd
Sources (1)
- FDA UDI 8b5b701a-cda3-4222-9d6a-131f9be89a64 32 fields · synced May 30, 2026