Identity
- Trade Name
- HUVITZ EUDAMEDOptical Biometer HBM-1 FDA UDI
- Generic Name
- Optical low coherence reflectometry (OLCR) biometer FDA UDI
- Device Name
- Optical Biometer EUDAMEDThe Optical Biometer HBM-1 is a medical device that optically measures eye components such as: *Axial length *Corneal curvature radii *Corneal cylinder axis *Anterior chamber depth *Central corneal thickness *Crystalline lens thickness *White-to-white *Pupil diameter The Optical Biometer HBM-1 also measures corneal topography. The Optical Biometer HBM-1 also performs calculations to assist physicians in determining the power of the intraocular lens for implantation. FDA UDI
- Model / Reference
- HBM-1 EUDAMEDFDA UDIV1XXCL-21-00001 EUDAMED
- Description
- The Optical Biometer HBM-1 is a medical device that optically measures eye components such as: *Axial length *Corneal curvature radii *Corneal cylinder axis *Anterior chamber depth *Central corneal thickness *Crystalline lens thickness *White-to-white *Pupil diameter The Optical Biometer HBM-1 also measures corneal topography. The Optical Biometer HBM-1 also performs calculations to assist physicians in determining the power of the intraocular lens for implantation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019600787 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196BM001AF EUDAMED
- Direct Marketing DI
- 08800019600787 EUDAMED
- FDA Product Code
- HJO FDA UDI
- EMDN Code
- Z12120102 COMPUTERISED OPTICAL BIOMETERS EUDAMED
- GMDN Term
- Optical low coherence reflectometry (OLCR) biometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1850 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 | 88000196BM001AF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
- EUDAMED SRN
- KR-MF-000015802
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 0112bf5f-d033-42d0-ab2f-6280dbc38e1f 61 fields · synced Jul 15, 2026
- FDA UDI 82eb3261-c452-4e70-be66-5d21bc13b8ef 33 fields · synced May 24, 2026