Identity
- Trade Name
- Lenstar LS 900 APS EUDAMEDLenstar LS 900 FDA UDI
- Generic Name
- Optical low coherence reflectometry (OLCR) biometer FDA UDI
- Device Name
- Lenstar LS 900 APS EUDAMED
- Model / Reference
- 1009001 EUDAMEDAPS FDA UDI
Identifiers
- Catalog Number
- 1009001 FDA UDI
- Primary DI / UDI-DI
- 07640132985832 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640132985832 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 420 Millimeter FDA UDIDepth — 260 Millimeter FDA UDIWidth — 310 Millimeter FDA UDI
Lenstar LS 900 APS by Haag-Streit AG — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640132985832 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Haag-Streit AG
- EUDAMED SRN
- CH-MF-000020981
- Authorised Representative
- Haag-Streit Deutschland GmbH DE-AR-000025462
Sources (2)
- EUDAMED c54cd554-8830-4b5e-a72c-40e71552b348 61 fields · synced Jun 17, 2026
- FDA UDI 2821a863-7b37-4f77-bbb1-d4ddce6c41c7 35 fields · synced May 29, 2026