Identity
- Trade Name
- Ophthalmic Unit EUDAMEDFDA UDI
- Generic Name
- Ophthalmic instrument table, manual FDA UDI
- Device Name
- Ophthalmic Unit EUDAMEDDelicate design and exquisite workmanship. Table liftable and rotatable. Convenient use for both adult and children. Rotary tray for auto refractometer and other optical devices. Electric lifting system for chair and arm. FDA UDI
- Model / Reference
- TCS-900 EUDAMEDTCS-880 EUDAMEDFDA UDI
- Description
- Delicate design and exquisite workmanship. Table liftable and rotatable. Convenient use for both adult and children. Rotary tray for auto refractometer and other optical devices. Electric lifting system for chair and arm. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971821406057 EUDAMEDFDA UDI
- Basic UDI-DI
- 69718214006VG EUDAMED
- Direct Marketing DI
- 06971821406057 EUDAMED
- FDA Product Code
- HRJ FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic instrument table, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4855 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
Yes
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
Ophthalmic Unit by Ningbo Ming Sing Optical R&D 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 | 69718214006VG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ningbo Ming Sing Optical R&D Co., Ltd.
- EUDAMED SRN
- CN-MF-000012092
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 2b78ecac-46be-49e8-812e-18799d029b87 61 fields · synced Jul 10, 2026
- FDA UDI fbcd8dd3-ea50-48f0-a302-0a220d86b145 34 fields · synced May 30, 2026