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CODMAN® CERTAS™ Plus 828852

by Integra LifeSciences Production Corporation

Ref 82-8852

CODMAN® CERTAS™ Plus 828852 (82-8852) is a device classified as Class III in the EU and Class II in the US made by Integra LifeSciences Production Corporation, registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI B-10381780532897), cleared under FDA 510(k) K181902 on 25 Oct 2018 and listed in FDA GUDID since 30 Apr 2020 (UDI-DI 10381780532897), active as of 23 Oct 2026.

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

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181902

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780532897 Basic UDI-DI 10381780532897UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780532897 UDI-DI Date30 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181902 Date25 Oct 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10381780532897 registered 17 Sep 2026 Active
  • FDA 510(k) K181902 decided 25 Oct 2018 Active
  • FDA GUDID UDI-DI 10381780532897 listed 30 Apr 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181902
  2. Listed FDA GUDID 10381780532897
  3. Registered EUDAMED B-10381780532897

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Codman Certas® EUDAMED
CODMAN® CERTAS™ Plus GUDID
Generic name
Cerebrospinal fluid shunt valve programmer
Device name
Electronic Tool Kit
Model / Ref / Catalog
82-8852, 828852
Primary DI / UDI-DI
10381780532897
Basic UDI-DI
B-10381780532897
510(k) Number
FDA product code
JXG
EMDN code
N01038099 Intracranial drainage devices and kits - accessories - other
GMDN term
Cerebrospinal fluid shunt valve programmer
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.5550
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
82-8852
GUDID
828852
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Cerebrospinal fluid shunt valve programmer

Similar devices in this category

Other devices filed under INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER.

Other devices from Integra LifeSciences Production Corporation

See all devices from Integra LifeSciences Production Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)