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Ocular Surface Analyzer DA-3
EUDAMEDFDA UDIClass I (EU MDR)
Ref 04Model DA-1,DA-3
Identity
- Trade Name
- Ocular Surface Analyzer DA-3 EUDAMEDOcular Surface Analyzer FDA UDI
- Generic Name
- Meibomian gland camera/ophthalmic interferometer FDA UDI
- Device Name
- Ocular Surface Analyzer EUDAMED
- Model / Reference
- DA-1,DA-3 EUDAMED04 EUDAMEDDA-3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973211070787 EUDAMEDFDA UDI
- Basic UDI-DI
- 69732110707OS9P EUDAMED
- FDA Product Code
- PJZ FDA UDI
- EMDN Code
- Q0299,Z12120108 EUDAMED
- GMDN Term
- Meibomian gland camera/ophthalmic interferometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1120 FDA UDI
- Market of Registration
- France 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Ocular Surface Analyzer DA-3 by Chongqing Sunkingdom Medical Instrument Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 69732110707OS9P | Class I | Active |
| 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.
- EUDAMED SRN
- CN-MF-000014351
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED ba9368cc-a168-475f-961d-a61b9115f82b 61 fields · synced Oct 6, 2026
- FDA UDI c4ff8832-6dfa-4ebe-af69-97dd0940cfb8 32 fields · synced May 30, 2026