Black Forest Medical GmbH

Certificate 1000297665

Rev. 04Supplemented

Valid until: Jul 5, 2028

Certificate 1000297665 is a valid Quality management system issued to Black Forest Medical GmbH and registered in EUDAMED. Valid until July 5, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 1000297665
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0297100029766504

Validity

Issued: Jan 29, 2026
Valid from: Jan 29, 2026
Valid until: Jul 5, 2028

Notified body

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

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: Basic UDI-DI data only

History

Status changes

Supplemented

Supersedes

1000261887AmendedSep 17, 2025 → Jul 4, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa3Class III2

5 scopes

MDN 1208 - Non-active non-implantable instruments
Class IIa
MDN 1208 - Non-active non-implantable instruments
Class III
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class III