Thermo Fisher Scientific Oy

Certificate HX 1070846-1

Rev. Rev. 3Supplemented

Valid until: Jan 31, 2028

Certificate HX 1070846-1 is a valid Quality management system issued to Thermo Fisher Scientific Oy and registered in EUDAMED. Valid until January 31, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1070846-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 4
Certificate ID: 0197HX 1070846-1Rev. 3

Validity

Issued: Jan 16, 2026
Valid from: Jan 16, 2026
Valid until: Jan 31, 2028

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: —
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

HX 1070846-1Quality management systemSupplementedJun 17, 2024 → Jan 31, 2028

Scope coverage

IVDR Class B5IVDR Class C4

9 scopes

CLINICAL CHEMISTRY IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers W01010103 - ALANINE AMINO-TRANSFERASE W01010105 - ALKALINE PHOSPHATASE – TOTAL W01010110 - ASPARTATE AMINO-TRANSFERASE W01010111 - CHOLINESTERASE W01010113 - CREATINE KINASE - TOTAL W01010116 - GAMMA GLUTAMYLTRANSFERASE W01010119 - LACTATE DEHYDROGENASE L (LDH - L-->P) W01010123 - LIPASE
IVDR Class B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0506: Other devices intended to be used to determine markers of infections/immune status. W01020101 - IMMUNOGLOBULINS (EXCEPT IGE W01021109 - C-REACTIVE PROTEIN W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 – STANDARDS AND CALIBRATORS
IVDR Class B
IMMUNOCHEMISTRY IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers W01020102 - COMPLEMENT COMPONENTS W01020103 - TRANSPORT PROTEINS W01020104 - LIPOPROTEINS W01020701 - ANEMIA W01021110 - RHEUMATOID FACTORS W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Class B
CLINICAL CHEMISTRY IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01010213 - GLUCOSE W01010214 – GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
IVDR Class C
CLINICAL CHEMISTRY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01010107 - AMYLASE - TOTAL W01010114 - CREATINE KINASE - MB ACTIVITY (CC) W01010230 - TOTAL PROTEIN W01010501 - MULTICOMPONENT CONTROLS (CLINICAL CHEMISTRY) W01010502 - SPECIFIC CONTROLS (CLINICAL CHEMISTRY) W01010503 - CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY)
IVDR Class C
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01030205 – FIBRINOLYSIS W01030207 - HAEMOSTASIS CALIBRATORS/CONTROLS
IVDR Class C
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01021109 - C-REACTIVE PROTEIN W01021520 - CONTROLS - IMMUNOCHEMISTRY
IVDR Class C
W01010302 - BICARBONATE W01010303 - CALCIUM W01010306 - MAGNESIUM W01010307 - PHOSPHATE INORGANIC / PHOSPHORUS W01010502 – SPECIFIC CONTROLS (CC) W01010503 - CALIBRATORS AND STANDARDS (CC) W01010606 - ELECTRODES OR CASSETTES FOR BLOOD GAS ANALYSIS INCL. ELECTROLYTES / METABOLITES - POC W01010701 - ELECTROLYTE ELECTRODES W01010703 - REFERENCE MATERIAL AND BUFFERS (ELECTROLYTES) W01019099 - CLINICAL CHEMISTRY REAGENTS – OTHER
IVDR Class B
W01010123 - LIPASE W01010201 - ALBUMIN (CC) W01010203 - BILIRUBIN W01010204 - UREA/BLOOD UREA NITROGEN W01010205 - CHOLESTEROL W01010207 - CREATININE W01010215 - HIGH DENSITY LIPOPROTEIN CHOLESTEROL W01010216 - IRON (CC) W01010221 - LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL W01010230 - TOTAL PROTEIN W01010231 - TRIGLYCERIDES W01010232 - URIC ACID
IVDR Class B

Documents

LanguagesEN

Scope coverage

IVDR Class B5IVDR Class C4

9 scopes

CLINICAL CHEMISTRY IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers W01010103 - ALANINE AMINO-TRANSFERASE W01010105 - ALKALINE PHOSPHATASE – TOTAL W01010110 - ASPARTATE AMINO-TRANSFERASE W01010111 - CHOLINESTERASE W01010113 - CREATINE KINASE - TOTAL W01010116 - GAMMA GLUTAMYLTRANSFERASE W01010119 - LACTATE DEHYDROGENASE L (LDH - L-->P) W01010123 - LIPASE
IVDR Class B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0506: Other devices intended to be used to determine markers of infections/immune status. W01020101 - IMMUNOGLOBULINS (EXCEPT IGE W01021109 - C-REACTIVE PROTEIN W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 – STANDARDS AND CALIBRATORS
IVDR Class B
IMMUNOCHEMISTRY IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers W01020102 - COMPLEMENT COMPONENTS W01020103 - TRANSPORT PROTEINS W01020104 - LIPOPROTEINS W01020701 - ANEMIA W01021110 - RHEUMATOID FACTORS W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Class B
CLINICAL CHEMISTRY IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01010213 - GLUCOSE W01010214 – GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
IVDR Class C
CLINICAL CHEMISTRY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01010107 - AMYLASE - TOTAL W01010114 - CREATINE KINASE - MB ACTIVITY (CC) W01010230 - TOTAL PROTEIN W01010501 - MULTICOMPONENT CONTROLS (CLINICAL CHEMISTRY) W01010502 - SPECIFIC CONTROLS (CLINICAL CHEMISTRY) W01010503 - CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY)
IVDR Class C
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01030205 – FIBRINOLYSIS W01030207 - HAEMOSTASIS CALIBRATORS/CONTROLS
IVDR Class C
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01021109 - C-REACTIVE PROTEIN W01021520 - CONTROLS - IMMUNOCHEMISTRY
IVDR Class C
W01010302 - BICARBONATE W01010303 - CALCIUM W01010306 - MAGNESIUM W01010307 - PHOSPHATE INORGANIC / PHOSPHORUS W01010502 – SPECIFIC CONTROLS (CC) W01010503 - CALIBRATORS AND STANDARDS (CC) W01010606 - ELECTRODES OR CASSETTES FOR BLOOD GAS ANALYSIS INCL. ELECTROLYTES / METABOLITES - POC W01010701 - ELECTROLYTE ELECTRODES W01010703 - REFERENCE MATERIAL AND BUFFERS (ELECTROLYTES) W01019099 - CLINICAL CHEMISTRY REAGENTS – OTHER
IVDR Class B
W01010123 - LIPASE W01010201 - ALBUMIN (CC) W01010203 - BILIRUBIN W01010204 - UREA/BLOOD UREA NITROGEN W01010205 - CHOLESTEROL W01010207 - CREATININE W01010215 - HIGH DENSITY LIPOPROTEIN CHOLESTEROL W01010216 - IRON (CC) W01010221 - LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL W01010230 - TOTAL PROTEIN W01010231 - TRIGLYCERIDES W01010232 - URIC ACID
IVDR Class B

Certificate HX 1070846-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate HX 1070846-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer