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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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MD Atlas
Documents

Huma Therapeutics Limited

Certificate 1000164455

Rev. 04Issued

Valid until: Mar 1, 2028

Overview

Certificate number: 1000164455
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0297100016445504

Validity

Issued: Feb 1, 2024
Valid from: Feb 1, 2024
Valid until: Mar 1, 2028

Manufacturer

Manufacturer: Huma Therapeutics Limited
Manufacturer SRN: GB-MF-000031420
Manufacturer country: United Kingdom

Notified body

Notified body: DQS Medizinprodukte GmbH
Notified body SRN: 0297
Notified body country: Germany

Covered devices

Huma Class IIb
++G287HUMAII7R
HUMA IGClass IIb
++G287HUMAIG7M

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data and Class IIb

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb3

3 scopes

MDA 0315 – Software
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb

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