Gebr. Brasseler GmbH & Co. KG

Certificate HZ 1470094-1

Rev. Rev. 5SupplementedExpired

Valid until: Feb 28, 2026

Overview

Certificate number: HZ 1470094-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 4
Certificate ID: 0197HZ 1470094-1Rev. 5

Validity

Issued: Jul 17, 2025
Valid from: Jul 17, 2025
Valid until: Feb 28, 2026

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: No
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: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

HZ 1470094-1Quality management systemSupplementedOct 23, 2024 → Feb 28, 2026

Scope coverage

Class IIa11Class I2

11 scopes

L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER
Class IIa
L159004 ENDODONTIC RASPS AND FILES, REUSABLE
Class IIaClass I
Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLEUSE
Class IIa
Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLEUSE
Class IIa
V0199 CUTTING DEVICES, SINGLE-USE - OTHER
Class IIa
Q010399 SURGICAL DENTAL DEVICES – OTHER
Class IIa
P091305 BONE SAWS, SINGLE-USE
Class IIa
Q010102 ROOT CANAL FILLING DEVICES
Class IIa
Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER
Class IIaClass I
L2499 DERMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE – OTHER
Class IIa
Q010502 DENTAL POLISHING CUPS, SINGLE-USE
Class IIa

Documents

LanguagesEN

Gebr. Brasseler GmbH & Co. KG

Certificate HZ 1470094-1

Rev. Rev. 5SupplementedExpired

Valid until: Feb 28, 2026

Overview

Certificate number: HZ 1470094-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 4
Certificate ID: 0197HZ 1470094-1Rev. 5

Validity

Issued: Jul 17, 2025
Valid from: Jul 17, 2025
Valid until: Feb 28, 2026

Manufacturer

Manufacturer: Gebr. Brasseler GmbH & Co. KG
Manufacturer SRN: DE-MF-000006446
Manufacturer country: Germany

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: No
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: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

HZ 1470094-1Quality management systemSupplementedOct 23, 2024 → Feb 28, 2026

Scope coverage

Class IIa11Class I2

11 scopes

L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER
Class IIa
L159004 ENDODONTIC RASPS AND FILES, REUSABLE
Class IIaClass I
Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLEUSE
Class IIa
Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLEUSE
Class IIa
V0199 CUTTING DEVICES, SINGLE-USE - OTHER
Class IIa
Q010399 SURGICAL DENTAL DEVICES – OTHER
Class IIa
P091305 BONE SAWS, SINGLE-USE
Class IIa
Q010102 ROOT CANAL FILLING DEVICES
Class IIa
Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER
Class IIaClass I
L2499 DERMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE – OTHER
Class IIa
Q010502 DENTAL POLISHING CUPS, SINGLE-USE
Class IIa

Documents

LanguagesEN