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Batroxobin Reagent 10873889

by Siemens Healthcare Diagnostics Products Ltd

Ref 10873889Model IVDR_27_MAR EB_C_REAG_Batrox

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686900899WQ Basic UDI-DI 00630414639611UDI-DIDate11 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414639611 UDI-DI Date25 Mar 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Batroxobin Reagent
Generic Name
Reptilase time IVD, reagent
Device Name
IVDR_27_MAR EB_C_REAG_Batrox
Model / Ref / Catalog
10873889, IVDR_27_MAR EB_C_REAG_Batrox
Primary DI / UDI-DI
00630414639611
Basic UDI-DI
0405686900899WQ
Unit of Use DI
00842768018725
510(k) Number
FDA Product Code
JCO
EMDN Code
W0103020103 Thrombin time / reptilase / batroxobin time
GMDN Term
Reptilase time IVD, reagent
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
864.8100
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class C
GUDID
Class II

Related devices

Category: Reptilase time IVD, reagent

Cleared under the same submission (K932787)

Similar devices

Also classified as Reptilase time IVD, reagent.

Other devices from Siemens Healthcare Diagnostics Products Ltd

See all devices from Siemens Healthcare Diagnostics Products Ltd →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No