HART BIOLOGICALS LTD

FDA Device Registration & Listing · Hartlepool, GB · Registration 3005261789

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005261789
FEI Number
3005261789
Entity Name
HART BIOLOGICALS LTD
City/State/Country
Hartlepool, GB
Establishment Address
2 Rivergreen Business Centre, Queens Meadow, Hartlepool TS25 2DL, GB
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Hart Biologicals Ltd (Owner Number: 10029879)
Owner / Operator Contact Address
Hart Biologicals Ltd., Queens Meadow, Hartlepool, GB-HPL TS25 2DL, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Sigma ROTROL N in-tem ROTROL N ROTROL P Sigma ROTROL P hep-tem (r) ex-tem fib-tem star-tem

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2021-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

Carol Marble Business: werfen Email: cmarble@werfen.com Phone: (781) 8614467

Related Public Records

Same Entity

Hart Biologicals Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K021022 Instrumentation Laboratory CO HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) 2002-05-14
K113211 Instrumentation Laboratory CO HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL 2012-01-04
K082859 Instrumentation Laboratory CO HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED 2008-12-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0514-2014 Instrumentation Laboratory Co. 2
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014 Instrumentation Laboratory Co. 2
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014 Instrumentation Laboratory Co. 2
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005261789. Last updated year: 2026. Please use registration number 3005261789 when referencing this establishment in official correspondence.
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