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Microclear
EUDAMEDFDA UDIClass I (EU MDR)
Ref HSL-01Model HSL,HSL-01,HSL-02,HSL-03
Identity
- Trade Name
- Microclear EUDAMEDFDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- Digital Hand-held Slit Lamp EUDAMED
- Model / Reference
- HSL,HSL-01,HSL-02,HSL-03 EUDAMEDHSL-01 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970990160074 EUDAMEDFDA UDI
- Basic UDI-DI
- 697099016HSLUL EUDAMED
- Direct Marketing DI
- 06970990160074 EUDAMED
- FDA Product Code
- PUE FDA UDI
- EMDN Code
- Z12120108 SLIT LAMPS EUDAMED
- GMDN Term
- Ophthalmic examination slit lamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1850 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Microclear by Suzhou Microclear Medical Instruments 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 | 697099016HSLUL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Suzhou Microclear Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000014411
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED b6eb4537-a91a-4dac-a812-844641f2866d 61 fields · synced Jul 26, 2026
- FDA UDI 86f5a501-9b6c-4e3c-a2b4-0a7850cb417d 32 fields · synced May 30, 2026