Identity
- Trade Name
- MED-Fibers, Inc. EUDAMEDMF-365/400-SBT FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Device Name
- MF-365/400-SBT EUDAMEDSurgical Laser Fiber 365/400/470/580, silicone, blue tefzel, NA 0.22, damage resistent SMA905, single use, gold extension sleeve, EO sterile, Flat Tip, MF label FDA UDI
- Model / Reference
- MF-365/400-SBT EUDAMEDFDA UDI
- Description
- Surgical Laser Fiber 365/400/470/580, silicone, blue tefzel, NA 0.22, damage resistent SMA905, single use, gold extension sleeve, EO sterile, Flat Tip, MF label FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00865325000131 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00865325000131 EUDAMED
- 510(k) Number
- K124003 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011003 HOLMIUM SURGICAL LASER EUDAMED
- GMDN Term
- General/multiple surgical laser system beam guide, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MED-Fibers, Inc. by Med -fibers Inc. — Class IIb — 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-00865325000131 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- MED-Fibers, Inc.
- EUDAMED SRN
- US-MF-000039524
- Authorised Representative
- Total-Laser Solution GmbH AT-AR-000021498
Sources (2)
- EUDAMED 0a813379-f7bb-45ea-8f0d-61e055e6377e 61 fields · synced Jul 11, 2026
- FDA UDI 84a744a0-8f7e-458d-835f-a2c4decbf369 34 fields · synced May 30, 2026