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Huvitz
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref M2ARAA-16-00001Model HTR-1A, HNT-1P, HNT-1, HT-5000Ref XXXXCL-25-00001Model HDC-9100 N, HDC-9100 PF, HCP-7000, HDC-100, HDC-9000 N, HDC-9000 PF
Identity
- Trade Name
- HUVITZ EUDAMEDNon-contact Tonometer HNT-1 FDA UDINon-contact Tonometer HNT-1P FDA UDI
- Generic Name
- Ophthalmic tonometer, battery-operated FDA UDI
- Device Name
- Tonometers EUDAMEDDigital Chart, Chart Projector, Visual Acuity Chart System EUDAMEDThe Non-Contact Tonometer is intended to be used to measure the intraocular pressure of the human eye. FDA UDINon-contact Tonometer HNT-1P FDA UDI
- Model / Reference
- HTR-1A, HNT-1P, HNT-1, HT-5000 EUDAMEDM2ARAA-16-00001 EUDAMEDHDC-9100 N, HDC-9100 PF, HCP-7000, HDC-100, HDC-9000 N, HDC-9000 PF EUDAMEDXXXXCL-25-00001 EUDAMEDHNT-1 FDA UDIHNT-1P FDA UDI
- Description
- The Non-Contact Tonometer is intended to be used to measure the intraocular pressure of the human eye. FDA UDINon-contact Tonometer HNT-1P FDA UDI
Identifiers
- Catalog Number
- HNT-1 FDA UDIHNT-1P FDA UDI
- Primary DI / UDI-DI
- 08800019600435 EUDAMEDFDA UDI08800019600428 EUDAMEDFDA UDI08800019601074 EUDAMED
- Basic UDI-DI
- 88000196NT001G4 EUDAMED88000196DC0018X EUDAMED
- Direct Marketing DI
- 08800019600435 EUDAMED08800019601074 EUDAMED08800019600428 EUDAMED
- FDA Product Code
- HKX FDA UDI
- EMDN Code
- Z12120116,Z12120122 EUDAMEDZ1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT EUDAMEDZ12120122 TONOMETERS EUDAMED
- GMDN Term
- Ophthalmic tonometer, battery-operated FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Market of Registration
- Germany EUDAMEDFrance 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
EUDAMEDEUDAMED
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
Huvitz by Huvitz 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 | 88000196NT001G4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
- EUDAMED SRN
- KR-MF-000015802
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (5)
- EUDAMED f74ff686-6d02-4c1f-b1a9-2e8c6d69c0ed 61 fields · synced Jul 10, 2026
- FDA UDI 09a5b070-9998-4f64-b7bf-60e4809ec058 35 fields · synced May 29, 2026
- FDA UDI 560171e0-8fe7-4918-ba16-6cae4a301505 35 fields · synced May 30, 2026
- EUDAMED 90759138-2099-4d3c-95f9-8cfdef6721cf 61 fields · synced Jul 9, 2026
- EUDAMED 81791574-4895-4fa2-a61c-fd66996292bf 61 fields · synced Jul 10, 2026