FOMED INDUSTRIES INC.

Certificate DZ 2372869-1

Rev. 0Issued

Valid until: Jul 16, 2028

Certificate DZ 2372869-1 is a valid Quality assurance issued to FOMED INDUSTRIES INC. and registered in EUDAMED. Valid until July 16, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: DZ 2372869-1
Certificate type: Quality assurance
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197DZ 2372869-10

Validity

Issued: Jul 17, 2023
Valid from: Jul 17, 2023
Valid until: Jul 16, 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: Yes
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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1Class I1

2 scopes

M020103-LAPAROTOMY COTTON GAUZES M020102-COTTON GAUZES, FOLDED
Class IIa
M020102-COTTON GAUZES, FOLDED M020201-NON-WOVEN FOLDED GAUZES M040201-ABSORBENT DRESSINGS WITH CELLULOSE PAD AND NON-WOVEN WRAPS
Class I

Documents

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