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Huvitz
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref TRXXCL-21-00002Model HTR-1A, HNT-1P, HNT-1, HT-5000
Identity
- Trade Name
- HUVITZ EUDAMEDAuto Tono/Refracto/Kerato/Pachymeter HTR-1A FDA UDI
- Generic Name
- Ophthalmic tonometer, battery-operated FDA UDI
- Device Name
- Tonometers EUDAMEDAuto Tono/Refracto/Kerato/Pachymeter HTR-1A FDA UDI
- Model / Reference
- HTR-1A, HNT-1P, HNT-1, HT-5000 EUDAMEDTRXXCL-21-00002 EUDAMEDHTR-1A FDA UDI
- Description
- Auto Tono/Refracto/Kerato/Pachymeter HTR-1A FDA UDI
Identifiers
- Catalog Number
- HTR-1A FDA UDI
- Primary DI / UDI-DI
- 08800019600558 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196NT001G4 EUDAMED
- Direct Marketing DI
- 08800019600558 EUDAMED
- FDA Product Code
- HKX FDA UDI
- EMDN Code
- Z12120113,Z12120116,Z12120122 EUDAMED
- GMDN Term
- Ophthalmic tonometer, battery-operated 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
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 (2)
- EUDAMED 157317c8-c427-45c2-ac47-d13efabfca69 61 fields · synced Jul 18, 2026
- FDA UDI b7415e86-1972-4a75-93f4-ac34cf8b0d01 35 fields · synced May 30, 2026