Identity
- Trade Name
- FEMTO Z8 NEO EUDAMEDFEMTO FDA UDI
- Generic Name
- Femtosecond ophthalmic solid-state laser system FDA UDI
- Device Name
- FEMTO LDV Z2 EUDAMED
- Model / Reference
- FEMTO EUDAMED510.003.009 EUDAMEDZ8 NEO FDA UDI
Identifiers
- Catalog Number
- 510.003.009 FDA UDI
- Primary DI / UDI-DI
- 07640167750573 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016775FLMDEVGN EUDAMED
- 510(k) Number
- K213559 FDA UDI
- FDA Product Code
- OOE 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
Yes
FDA UDI
Femto Z8 Neo 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 7ef3c0a8-989d-4aaf-a79e-4badf7b357c1 61 fields · synced Jun 20, 2026
- FDA UDI 89e0e5ff-760a-4d46-9aa0-5e4208098f9b 36 fields · synced May 30, 2026