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PrintMate™ Embedding Cassette

by Richard-Allan Scientific LLC 48 variants

Ref B851070OR

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, self-declared

Class I: no certifier involved

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 Number0673693RAS001R7 Basic UDI-DI 00673693757553UDI-DIDate13 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00673693757553 UDI-DI Date23 Aug 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
PrintMate™ Embedding Cassette EUDAMED
Epredia GUDID
Generic Name
Histology tissue cassette IVD, laboratory processing, single-use
Model / Ref / Catalog
B851070OR, PrintMate™ Embedding Cassette
Primary DI / UDI-DI
00673693757553
Basic UDI-DI
0673693RAS001R7
Unit of Use DI
00673693003964
FDA Product Code
IDZ
EMDN Code
W05020106 Biopsy cartridges
GMDN Term
Histology tissue cassette IVD, laboratory processing, single-use
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.3010
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
B851070OR
GUDID
PrintMate™ Embedding Cassette
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

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

Other devices from Richard-Allan Scientific LLC

See all devices from Richard-Allan Scientific LLC →

Properties

  • Single Use
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: 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