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Non Contact Tonometer Nt-510
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref B01E013Model NT-1/NT-1e
Identity
- Trade Name
- NON CONTACT TONOMETER NT-510 EUDAMEDNON CONTACT TONOMETER FDA UDI
- Generic Name
- Ophthalmic tonometer, line-powered FDA UDI
- Device Name
- The NON CONTACT TONOMETER Model NT-510 is designed for non-contact tonometry measurement. The non-contact tonometry function measures the intraocular pressure without contacting the eye. Tonometry is performed for screening of glaucoma, and for preoperative examination and postoperative care in ophthalmology. FDA UDI
- Model / Reference
- NT-1/NT-1e EUDAMEDB01E013 EUDAMEDNT-510 FDA UDI
- Description
- The NON CONTACT TONOMETER Model NT-510 is designed for non-contact tonometry measurement. The non-contact tonometry function measures the intraocular pressure without contacting the eye. Tonometry is performed for screening of glaucoma, and for preoperative examination and postoperative care in ophthalmology. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100424 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669203G6 EUDAMED
- FDA Product Code
- HKX FDA UDI
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
- GMDN Term
- Ophthalmic tonometer, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Non Contact Tonometer Nt-510 by Nidek Co., Ltd. — Class IIa — 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 | 4987669203G6 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- NIDEK.CO.Ltd.,
- EUDAMED SRN
- JP-MF-000040151
- Authorised Representative
- NIDEK SA FR-AR-000000341
Sources (2)
- EUDAMED ce5360b1-12ab-454f-98fd-aac67b9b6f8b 61 fields · synced Jul 28, 2026
- FDA UDI f838bbc5-0fe1-4b60-b734-10839aae85cb 34 fields · synced May 29, 2026