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Atellica CH Alkaline Phosphatase, Concentrated (ALP_2c)

by Siemens Healthcare Diagnostics Inc.

Ref 11645758Model IVDR_67_TTN_DUB-C_B_REAG_ALP_2c

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 Number0405686900763VW Basic UDI-DI 00630414654102UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414654102 UDI-DI Date8 Apr 2026ListedStatusListed 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  • Withdrawn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 Alkaline Phosphatase, Concentrated (ALP_2c) EUDAMED
Atellica CH ALP_2c GUDID
Generic Name
Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry
Device Name
IVDR_67_TTN_DUB-C_B_REAG_ALP_2c
Model / Ref / Catalog
IVDR_67_TTN_DUB-C_B_REAG_ALP_2c, 11645758
Primary DI / UDI-DI
00630414654102
Basic UDI-DI
0405686900763VW
Unit of Use DI
00630414322094
510(k) Number
FDA Product Code
CJO
EMDN Code
W01010105 Alkaline phosphatase - total
GMDN Term
Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
862.1050
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000016560
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

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See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

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

Other properties (20)

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