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PermaFluor Aqueous Mounting Medium

by Richard-Allan Scientific LLC 2 variants

Ref TA-006-FM

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0673693RAS053RS Basic UDI-DI 00673693404426UDI-DIDate4 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00673693404426 UDI-DI Date1 Jun 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
PermaFluor Aqueous Mounting Medium EUDAMED
Thermo Scientific GUDID
Generic Name
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Device Name
Ancillary Products
Model / Reference
TA-006-FM
Primary DI / UDI-DI
00673693404426
Basic UDI-DI
0673693RAS053RS
Direct Marketing DI
00673693404426
FDA Product Code
NJT, LED
EMDN Code
W01030711 Immunohistology kits
GMDN Term
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.1860, 864.1850
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 6 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000008261
Authorised representative
Epredia Netherlands B.V. NL-AR-000001488

Related devices

Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Other devices from Richard-Allan Scientific LLC

See all devices from Richard-Allan Scientific LLC →

Properties

  • Reagent
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No