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Surgical Fiber Optic Assembly

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref MFR 600 HPCS BlueModel Surgical Fiber Optic Assembly

by MED-Fibers, Inc.

Identity

Trade Name
Surgical Fiber Optic Assembly EUDAMED
MFR-600-HPCS-Blue FDA UDI
Generic Name
General/multiple surgical laser system beam guide, reusable FDA UDI
Device Name
MFR 600 HPCS Blue EUDAMED
Surgical Laser Fiber, 600/630/950, hard clad, clear tefzel, NA0.37, standard SMA905, 5x reusable, luer lock adapter, silver extension sleeve, EO sterile, Flat Tip, MF label FDA UDI
Model / Reference
Surgical Fiber Optic Assembly EUDAMED
MFR 600 HPCS Blue EUDAMED
MFR-600-HPCS-Blue FDA UDI
Description
Surgical Laser Fiber, 600/630/950, hard clad, clear tefzel, NA0.37, standard SMA905, 5x reusable, luer lock adapter, silver extension sleeve, EO sterile, Flat Tip, MF label FDA UDI

Identifiers

Primary DI / UDI-DI
00855950006271 EUDAMEDFDA UDI
Basic UDI-DI
B-00855950006271 EUDAMED
510(k) Number
K124003 FDA UDI
FDA Product Code
GEX FDA UDI
EMDN Code
Z1201118099 INSTRUMENTS FOR OPERATIVE MICROSCOPY - HARDWARE ACCESSORIES - OTHER EUDAMED
GMDN Term
General/multiple surgical laser system beam guide, reusable FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

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

Surgical Fiber Optic Assembly 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

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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 c23ee1dc-fd4d-4d61-be25-47f29c8973a8 61 fields · synced Jun 18, 2026
  • FDA UDI ca7f1c69-76a3-4845-a46f-39035fbdf9d3 34 fields · synced May 22, 2026