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OptaBlate 9900110200

by Stryker Corp.

Ref 9900-110-200Model 08858251007130T3

OptaBlate 9900110200 (9900-110-200) is a device classified as Class IIb in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 30 Jul 2026 (Basic UDI-DI 08858251007130T3) and listed in FDA GUDID since 27 May 2025 (UDI-DI 07613327601169), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251007130T3 Basic UDI-DI 07613327601169UDI-DIDate30 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327601169 UDI-DI Date27 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251007130T3 registered 30 Jul 2026 Active
  • FDA GUDID UDI-DI 07613327601169 listed 27 May 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327601169
  2. Registered EUDAMED 08858251007130T3

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
OptaBlate
Generic name
Neurosurgical procedure kit, non-medicated, single-use
Device name
RF Nerve Ablation Probes
Model / Ref / Catalog
08858251007130T3, 9900-110-200, 9900110200
Primary DI / UDI-DI
07613327601169
Basic UDI-DI
08858251007130T3
FDA product code
GXI
EMDN code
Z12010980 Electrosurgery instruments - hardware accessories
GMDN term
Neurosurgical procedure kit, non-medicated, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.4725
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251007130T3
9900-110-200
GUDID
9900110200
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Neurosurgical procedure kit, non-medicated, single-usePercutaneous radio-frequency ablation probe, denervation, bipolar

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

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