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Auto Lensmeter
EUDAMEDFDA UDIClass I (EU MDR)
Ref B6ARAA-17-00003Model HLM-1, HLM-7000P, HLM-9000
Identity
- Trade Name
- Auto Lensmeter HLM-1 FDA UDI
- Generic Name
- Manually-adjusted lensmeter, line-powered FDA UDI
- Device Name
- Auto Lensmeter EUDAMEDLensmeter is a machine to generate Sph, Cyl and Axis information of lens by measuring refraction of the lens FDA UDI
- Model / Reference
- HLM-1, HLM-7000P, HLM-9000 EUDAMEDB6ARAA-17-00003 EUDAMEDHLM-1 FDA UDI
- Description
- Lensmeter is a machine to generate Sph, Cyl and Axis information of lens by measuring refraction of the lens FDA UDI
Identifiers
- Catalog Number
- HLM-1 FDA UDI
- Primary DI / UDI-DI
- 08800019600442 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196LM001DV EUDAMED
- Direct Marketing DI
- 08800019600442 EUDAMED
- FDA Product Code
- HLM FDA UDI
- EMDN Code
- Z12129099 VARIOUS OPHTALMOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Manually-adjusted lensmeter, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1425 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
Auto Lensmeter by Huvitz 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 | 88000196LM001DV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 c14ce592-7667-450e-90c6-7a13ccfa6794 61 fields · synced Jul 9, 2026
- FDA UDI 16095fb5-7293-467f-bdfc-a87bbc676feb 35 fields · synced May 30, 2026