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Ophthalmic Unit
EUDAMEDFDA UDIClass I (EU MDR)
Ref TCS-680Model TCS-900Ref TCS-860
Identity
- Trade Name
- Ophthalmic Unit EUDAMEDFDA UDI
- Generic Name
- Ophthalmic instrument table, manual FDA UDI
- Device Name
- Ophthalmic Unit EUDAMEDA mains electricity (AC-powered) device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments (e.g., slit lamp, keratometer, refractometer, and hand instruments) for the examination/treatment of a patient's eyes. It has powered height adjustments enabling the clinician to raise/lower the surface, or seated patient, to align the instruments to the patient's eye level. Some designs may incorporate the patient chair as part of the unit and even facilitate easy swinging aside mechanisms to accommodate wheelchair bound patients. Controls may enable the adjustment of peripheral devices within the examination room. FDA UDI
- Model / Reference
- TCS-900 EUDAMEDFDA UDITCS-680 EUDAMEDTCS-860 EUDAMED
- Description
- A mains electricity (AC-powered) device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments (e.g., slit lamp, keratometer, refractometer, and hand instruments) for the examination/treatment of a patient's eyes. It has powered height adjustments enabling the clinician to raise/lower the surface, or seated patient, to align the instruments to the patient's eye level. Some designs may incorporate the patient chair as part of the unit and even facilitate easy swinging aside mechanisms to accommodate wheelchair bound patients. Controls may enable the adjustment of peripheral devices within the examination room. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971821406095 EUDAMED06971821406064 EUDAMEDFDA UDI06971821406002 EUDAMED
- Basic UDI-DI
- 69718214006VG EUDAMED
- Direct Marketing DI
- 06971821406095 EUDAMED06971821406064 EUDAMED06971821406002 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 (4)
- EUDAMED 31c54c67-9028-4ef7-a15a-4fcfc6093877 61 fields · synced Jul 28, 2026
- EUDAMED f52e3db6-f541-4644-97f7-012161578ac6 61 fields · synced May 18, 2026
- EUDAMED 73e27943-93f7-47c5-8e37-a0de5fa274e9 61 fields · synced May 18, 2026
- FDA UDI 38d991d4-987c-43a1-877d-da302c114fd7 34 fields · synced May 30, 2026