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Cer-Sub-825

by Ranfac Corp. 2 variants

Part of a family of 33 devices: see the family page

Ref 74385-01MModel RAN

Cer-Sub-825 (74385-01M) is a device classified as Class IIa in the EU and Class II in the US made by Ranfac Corp., registered in EUDAMED on 2 Mar 2022 (Basic UDI-DI 08586900068300101G5), cleared under FDA 510(k) K131157 on 22 Oct 2013 and listed in FDA GUDID since 14 Oct 2021 (UDI-DI 00850023741363), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K131157

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08586900068300101G5 Basic UDI-DI 00850023741363UDI-DIDate2 Mar 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00850023741363 UDI-DI Date14 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK131157 Date22 Oct 2013IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08586900068300101G5 registered 2 Mar 2022 Active
  • FDA 510(k) K131157 decided 22 Oct 2013 Active
  • FDA GUDID UDI-DI 00850023741363 listed 14 Oct 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131157
  2. Listed FDA GUDID 00850023741363
  3. Registered EUDAMED 08586900068300101G5

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Bone access cannula
Device name
Ranfac Bone Marrow Aspiration Needle
Model / Ref / Catalog
RAN EUDAMED
74385-01M EUDAMED
8 GA X 25 CM GUDID
CER-SUB-825 GUDID
Description
CER-SUB-825 PN: 74385-01M
Primary DI / UDI-DI
00850023741363
Basic UDI-DI
08586900068300101G5
Direct marketing DI
00850023741363
510(k) Number
FDA product code
KNW
EMDN code
A01020102 Aspiration fine needles and kits
GMDN term
Bone access cannula
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1075
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 25 Centimeter
Needle Gauge — 8 Gauge

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
RAN
74385-01M
GUDID
8 GA X 25 CM
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00850023741363: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000008871
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Diskectomy system, percutaneous, automatic

Similar devices in this category

Other devices filed under ASPIRATION FINE NEEDLES AND KITS.

Other devices from Ranfac Corp.

See all devices from Ranfac Corp. →

Properties

  • Supplied sterile
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)