East Midlands Pharma Limited

Certificate ECM23MDR001

Rev. 2Supplemented

Valid until: May 11, 2028

Certificate ECM23MDR001 is a valid Quality management system issued to East Midlands Pharma Limited and registered in EUDAMED. Valid until May 11, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: ECM23MDR001
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 1282ECM23MDR0012

Validity

Issued: Oct 18, 2024
Valid from: Oct 18, 2024
Valid until: May 11, 2028

Manufacturer

Manufacturer: East Midlands Pharma Limited
Manufacturer SRN: GB-MF-000009146
Manufacturer country: United Kingdom

Notified body

Notified body: ENTE CERTIFICAZIONE MACCHINE SRL
Notified body SRN: 1282
Notified body country: Italy

Covered devices

No specific devices are listed for this certificate.

Characteristics

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

History

Status changes

Supplemented

Supersedes

ECM23MDR001Quality management systemSupplementedJul 19, 2024 → May 11, 2028

Scope coverage

Class IIb3

3 scopes

DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb

Documents

LanguagesITEN