KERMA Verbandstoff GmbH

Certificate DZ 1625800-1

Rev. Rev. 1Reissued

Valid until: May 3, 2031

Certificate DZ 1625800-1 is a valid Quality assurance issued to KERMA Verbandstoff GmbH and registered in EUDAMED. Valid until May 3, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: DZ 1625800-1
Certificate type: Quality assurance
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197DZ 1625800-1Rev. 1

Validity

Issued: May 3, 2026
Valid from: May 4, 2026
Valid until: May 3, 2031

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: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Supersedes

DZ 1625800-1IssuedMay 3, 2021 → May 2, 2026

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class I7

7 scopes

Products of class I, sterile: M010102 PURE COTTON
Class I
Products of class I, sterile: M020101 COTTON GAUZES, CUT
Class I
Products of class I, sterile: M020102 COTTON GAUZES, FOLDED
Class I
Products of class I, sterile: M020199 COTTON GAUZES - OTHERS
Class I
Products of class I, sterile: M020299 NON-WOVEN GAUZES - OTHER
Class I
Products of class I, sterile: M040301 EYE PADS, COTTON OR NON-WOVEN MATERIALS
Class I
Products of class I, sterile: M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions
Class I

Documents

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