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Codman Certas® 828859

by Integra LifeSciences Switzerland Sàrl

Ref 82-8859

Codman Certas® 828859 (82-8859) is a device classified as Class I in the EU and Class II in the US made by Integra LifeSciences Switzerland Sàrl, registered in EUDAMED on 26 Jun 2026 (Basic UDI-DI 038178B0076CSS4R), cleared under FDA 510(k) K143111 on 19 Feb 2015 and listed in FDA GUDID since 28 Feb 2020 (UDI-DI 10381780521334), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143111

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038178B0076CSS4R Basic UDI-DI 10381780521334UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780521334 UDI-DI Date28 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK143111 Date19 Feb 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038178B0076CSS4R registered 26 Jun 2026 Active
  • FDA 510(k) K143111 decided 19 Feb 2015 Active
  • FDA GUDID UDI-DI 10381780521334 listed 28 Feb 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K143111
  2. Listed FDA GUDID 10381780521334
  3. Registered EUDAMED 038178B0076CSS4R

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  • Withdrawn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

Trade name
Codman Certas®
Generic name
Cerebrospinal fluid shunt valve programmer
Device name
ICP Programmer
Model / Ref / Catalog
82-8859, 828859
Primary DI / UDI-DI
10381780521334
Basic UDI-DI
038178B0076CSS4R
Unit of use DI
00381780521337
510(k) Number
FDA product code
JXG
EMDN code
Z12109003 Cerebrospinal fluid pressure monitoring systems
GMDN term
Cerebrospinal fluid shunt valve programmer
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5550
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
82-8859
GUDID
828859
Device classEUDAMED
Class I
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 10381780521334: EUDAMED states Yes, FDA GUDID states No.

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: Cerebrospinal fluid shunt valve programmer

Cleared under the same submission (K143111)

Similar devices in this category

Other devices filed under VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS.

Other devices from Integra LifeSciences Switzerland Sàrl

See all devices from Integra LifeSciences Switzerland Sàrl →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)