Identity
- Trade Name
- MED-Fibers, Inc. EUDAMEDTXMF600BFS FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Device Name
- TXMF600BFS EUDAMEDBare Fiber 600um 3m, luer lock, SMA Connector, sterile FDA UDI
- Model / Reference
- TXMF600BFS EUDAMEDFDA UDI
- Description
- Bare Fiber 600um 3m, luer lock, SMA Connector, sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855950006745 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00855950006745 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
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Welcome to the MED-Fibers, Inc. directory, your one-stop resource for information on the latest medical devices. Our flagship product, TXMF600BFS, is a cutting-edge solution in the field of endoscopy, offering unparalleled precision and reliability. By providing an overview of its features, compliance status, and regulatory requirements, we aim to empower healthcare professionals to make informed decisions about our device.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00855950006745 | 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 7b58a093-4719-45fe-987e-4a72c7045c6d 61 fields · synced Jul 19, 2026
- FDA UDI ba184e1d-f52f-4362-9a35-b92b6d4c27b4 34 fields · synced May 30, 2026