BRM Extremities S.r.l.

Certificate 059-00-02-MDR

Rev. 02Supplemented

Valid until: Sep 19, 2029

Overview

Certificate number: 059-00-02-MDR
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0426059-00-02-MDR02

Validity

Issued: Dec 3, 2025
Valid from: Dec 3, 2025
Valid until: Sep 19, 2029

Notified body

Notified body: ITALCERT SRL
Notified body SRN: 0426
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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

059-00-01-MDRQuality management systemSupplementedSep 29, 2025 → Sep 19, 2029

Scope coverage

Class IIa5Class I5Class IIb2Class III1

12 scopes

Non-active osteo- and orthopaedic implants
Class IIb
Non-active non-implantable instruments
Class IIaClass I
Osteosynthesis screw
Class IIb
Accessories for the implantation of osteosynthesis screws
Class I
Accessories for the implant of device SILKTOE
Class I
Accessories for the implant of BIOPLAN device
Class I
Accessories for the implant of DIGITALIS device
Class I
Accessories for the implantation of osteosynthesis screws
Class IIa
Accessories for the implant of device SILKTOE
Class IIa
Accessories for the implant of device BIOPLAN
Class IIa
Accessories for the implant of device DIGITALIS
Class IIa
Foot prostheses metatarsalphalangeal components
Class III

Documents

LanguagesENIT

BRM Extremities S.r.l.

Certificate 059-00-02-MDR

Rev. 02Supplemented

Valid until: Sep 19, 2029

Overview

Certificate number: 059-00-02-MDR
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0426059-00-02-MDR02

Validity

Issued: Dec 3, 2025
Valid from: Dec 3, 2025
Valid until: Sep 19, 2029

Manufacturer

Manufacturer: BRM Extremities S.r.l.
Manufacturer SRN: IT-MF-000016087
Manufacturer country: Italy

Notified body

Notified body: ITALCERT SRL
Notified body SRN: 0426
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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

059-00-01-MDRQuality management systemSupplementedSep 29, 2025 → Sep 19, 2029

Scope coverage

Class IIa5Class I5Class IIb2Class III1

12 scopes

Non-active osteo- and orthopaedic implants
Class IIb
Non-active non-implantable instruments
Class IIaClass I
Osteosynthesis screw
Class IIb
Accessories for the implantation of osteosynthesis screws
Class I
Accessories for the implant of device SILKTOE
Class I
Accessories for the implant of BIOPLAN device
Class I
Accessories for the implant of DIGITALIS device
Class I
Accessories for the implantation of osteosynthesis screws
Class IIa
Accessories for the implant of device SILKTOE
Class IIa
Accessories for the implant of device BIOPLAN
Class IIa
Accessories for the implant of device DIGITALIS
Class IIa
Foot prostheses metatarsalphalangeal components
Class III

Documents

LanguagesENIT