Identity
- Trade Name
- FEMTO LDV Z4 EUDAMEDFEMTO LDV FDA UDI
- Generic Name
- Femtosecond ophthalmic solid-state laser system FDA UDI
- Device Name
- FEMTO LDV Z2 EUDAMED
- Model / Reference
- FEMTO EUDAMED510.003.004 EUDAMEDZ4 FDA UDI
Identifiers
- Catalog Number
- 510.003.004 FDA UDI
- Primary DI / UDI-DI
- 07640167750030 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016775FLMDEVGN EUDAMED
- 510(k) Number
- K112154 FDA UDI
- FDA Product Code
- HQF FDA UDI
- EMDN Code
- Q020199 OPHTHALMIC CUTTING DEVICES - OTHER EUDAMED
- GMDN Term
- Femtosecond ophthalmic solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4390 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Femto Ldv Z4 by SIE AG, Surgical Instrument Engineering — Class IIb — 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 | 764016775FLMDEVGN | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- SIE AG, Surgical Instrument Engineering
- EUDAMED SRN
- CH-MF-000025018
- Authorised Representative
- Ziemer Ophthalmology (DE) GmbH DE-AR-000005638
Sources (2)
- EUDAMED 39c33737-8b3a-4773-bbba-2f220828ad54 61 fields · synced Jul 20, 2026
- FDA UDI 5e7e7667-cf99-4ad5-95bc-f92e39c8e281 36 fields · synced May 29, 2026