Identity
- Trade Name
- Portable Slit Lamp EUDAMEDMediworks FDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- Portable Slit Lamp EUDAMED
- Model / Reference
- S150 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945087515013 EUDAMEDFDA UDI
- Basic UDI-DI
- 69450875PortableSlitZH EUDAMED
- Direct Marketing DI
- 06945087515013 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
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Portable Slit Lamp by Shanghai Mediworks Precision Instruments Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100439 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69450875PortableSlitZH | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Mediworks Precision Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000004251
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED e69f0f4c-7ee9-447d-bece-ea3933af938a 61 fields · synced Jun 19, 2026
- FDA UDI 62d676a3-c951-41d6-8bba-8100fa2582c9 32 fields · synced May 30, 2026
- FDA 510(k) K100439 1 fields · synced May 18, 2026