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Atellica CH NAPA 11097537

by Siemens Healthcare Diagnostics Inc.

Ref 11097537Model IVDR_67_TTN_DUB-C_C_REAG_N-Acetylprocainamide

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 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901860W4 Basic UDI-DI 00630414220659UDI-DIDate14 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414220659 UDI-DI Date8 Oct 2018ListedStatusListed 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 23 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  • Withdrawn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
Atellica CH N-Acetylprocainamide (NAPA) EUDAMED
Atellica CH NAPA GUDID
Generic Name
N-acetyl procainamide (NAPA) IVD, kit, nephelometry/turbidimetry
Device Name
IVDR_67_TTN_DUB-C_C_REAG_N-Acetylprocainamide
Model / Ref / Catalog
11097537, IVDR_67_TTN_DUB-C_C_REAG_N-Acetylprocainamide
Primary DI / UDI-DI
00630414220659
Basic UDI-DI
0405686901860W4
510(k) Number
FDA Product Code
LAN
EMDN Code
W0102080106 N-acetylprocainamide
GMDN Term
N-acetyl procainamide (NAPA) IVD, kit, nephelometry/turbidimetry
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
862.3320
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: N-acetyl procainamide (NAPA) IVD, kit, nephelometry/turbidimetry

Cleared under the same submission (K032564)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

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

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: 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