ARCHImedline GmbH

Austria AT-MF-000037501 Last updated 8 Jun 2026

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Devices: 19
Registries: EUDAMED
FDA recalls: 0

Catalogue19

Mobile Phase 001 Ref M001-01

Class A EUDAMED Active
Lyso Triplex Ref A290

Class B EUDAMED Active
HPLC Column 001 Ref C001-01

Class A EUDAMED Active
PEth from whole blood Ref A371

Class B EUDAMED Active
Control set – Level I – III for PEth from whole blood Ref A371-012

Class B EUDAMED Active
Control IV for PEth from whole blood Ref A371-081

Class B EUDAMED Active
Column guard 001 Ref C001-02

Class A EUDAMED Active
HPLC column for PEth from whole blood Ref A371-090

Class A EUDAMED Active
HPLC column 2 for PEth from whole blood Ref A371-091

Class A EUDAMED Active
Optimization mix for PEth from whole blood Ref A371-006

Class A EUDAMED Active
Extraction solution with internal standard for Lyso Triplex Ref A290-010

Class B EUDAMED Active
Mobile Phase 002 Ref M002-02

Class A EUDAMED Active
Mobile Phase 001 Ref M001-02

Class A EUDAMED Active
Control-Set: (DBS Control-Set – Level I, II, III for Lyso Triplex) Ref A290-012

Class B EUDAMED Active
Mobile Phase for PEth from whole blood Ref A371-001

Class A EUDAMED Active
Calibrator 7 for PEth from whole blood Ref A371-080

Class B EUDAMED Active
Precipitation solution with internal standard for PEth from whole blood Ref A371-010

Class B EUDAMED Active
Washing solution 001 Ref W001-01

Class A EUDAMED Active
Calibrator-Set: (DBS Calibrator-Set – Level 0-6 for Lyso Triplex) Ref A290-011

Class B EUDAMED Active
Mobile Phase 002 Ref M002-01

Class A EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

QMD Services GmbH 2962 1 certificate

IQMS/00010/0v002 Supplemented

Quality management system EU IVDR

Issued
27 Jul 2026

Expires
8 Jul 2031

Reason
Add device or group

Notified bodies

QMD Services GmbH 2962

About

ARCHImedline reaches an important regulatory milestone: Our quality management system has been approved by the Notified Body QMD Services GmbH (NB 2962) in accordance with the..

Translated from the manufacturer's own website. Source

Information

Country: Austria
Address: 20/2, Leberstrasse, Vienna, Austria
Website: www.archimedline.com
LinkedIn: linkedin.com/company/archimedline
Email: [email protected]
Phone: +4313940020
PRRC contact: David Kasper
EUDAMED SRN: AT-MF-000037501

Catalogue19

Mobile Phase 001 Ref M001-01

Lyso Triplex Ref A290

HPLC Column 001 Ref C001-01

PEth from whole blood Ref A371

Control set – Level I – III for PEth from whole blood Ref A371-012

Control IV for PEth from whole blood Ref A371-081

Column guard 001 Ref C001-02

HPLC column for PEth from whole blood Ref A371-090

HPLC column 2 for PEth from whole blood Ref A371-091

Optimization mix for PEth from whole blood Ref A371-006

Extraction solution with internal standard for Lyso Triplex Ref A290-010

Mobile Phase 002 Ref M002-02

Mobile Phase 001 Ref M001-02

Control-Set: (DBS Control-Set – Level I, II, III for Lyso Triplex) Ref A290-012

Mobile Phase for PEth from whole blood Ref A371-001

Calibrator 7 for PEth from whole blood Ref A371-080

Precipitation solution with internal standard for PEth from whole blood Ref A371-010

Washing solution 001 Ref W001-01

Calibrator-Set: (DBS Calibrator-Set – Level 0-6 for Lyso Triplex) Ref A290-011

Mobile Phase 002 Ref M002-01

EUDAMED certificates1

QMD Services GmbH 2962 ·1 certificate

Related companies

Notified bodies

About

Information

QMD Services GmbH 2962 1 certificate