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BD Surepath Sample Collection Kit 490525

by CooperSurgical, Inc.

Part of a family of 7 devices: see the family page

Ref 490525Model 70124-001

BD Surepath Sample Collection Kit 490525 is a device classified as Class I in the EU and Class II in the US made by CooperSurgical, Inc., registered in EUDAMED on 22 May 2026 (Basic UDI-DI 0888937TD006ns2S), cleared under FDA 510(k) K861389 on 2 May 1986 and listed in FDA GUDID since 21 Sep 2018 (UDI-DI 60888937021402), active as of 7 Nov 2026.

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

CE MDR CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K861389

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number0888937TD006ns2S Basic UDI-DI 60888937021402UDI-DIDate22 May 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number0888937TD006ns2S Basic UDI-DI 60888937021402UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number60888937021402 UDI-DI Date21 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK861389 Date2 May 1986DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0888937TD006ns2S registered 22 May 2026 Active· +1 more in the status table
  • FDA 510(k) K861389 decided 2 May 1986 Active
  • FDA GUDID UDI-DI 60888937021402 listed 21 Sep 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K861389
  2. Listed FDA GUDID 60888937021402
  3. Registered EUDAMED 0888937TD006ns2S

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
BD SurePath™ EUDAMED
BD Surepath Sample Collection Kit GUDID
Generic name
Urogenital specimen collection kit IVD, clinical
Device name
Medscand® Sample Collection Kit
BD SurePath Sample Collection Devices
Model / reference
490525, 70124-001
Primary DI / UDI-DI
60888937021402 EUDAMED
20888937021404 GUDID
Basic UDI-DI
0888937TD006ns2S, B-60888937021402
510(k) Number
FDA product code
HHT
EMDN code
W02020502 Cervical screening systems
GMDN term
Urogenital specimen collection kit IVD, clinical
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.4530
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
60888937021402
GUDID
20888937021404
Device classEUDAMED
Class I
GUDID
Class II
Supplied sterileEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists 60888937021402; FDA GUDID lists 20888937021404), so their flags are not compared. Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Urogenital specimen collection kit IVD, clinical

Cleared under the same submission (K861389)

Similar devices in this category

Other devices filed under HISTOLOGY / CYTOLOGY.

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

  • Supplied sterile NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)