ChM spółka z ograniczoną odpowiedzialnością

Certificate HZ 1023642-1

Rev. 12Issued

Valid until: Apr 29, 2030

Certificate HZ 1023642-1 is a valid Quality management system issued to ChM spółka z ograniczoną odpowiedzialnością and registered in EUDAMED. Valid until April 29, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1023642-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 1023642-112

Validity

Issued: Jan 19, 2026
Valid from: Jan 19, 2026
Valid until: Apr 29, 2030

Manufacturer

Manufacturer: ChM spółka z ograniczoną odpowiedzialnością
Manufacturer SRN: PL-MF-000002121
Manufacturer country: Poland

Notified body

Notified body
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: Yes
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I51Class IIb7Class IIa5Class III2Unspecified1

66 scopes

L091099 - Osteosynthesis instruments, reusable – other
Class I
L090403 - Orthopaedic surgery gouges, reusable
Class I
L0903 - Orthopaedic surgery hammers, reusable
Class I
L091001 - Instruments for insertion and extraction of materials for osteosynthesis, reusable.
Class I
L0916 - Orthopaedic surgery burs and tips, reusable
Class I
L03140199 - Spreaders and retractors for general surgery, reusable - other.
Class I
L0908 - Orthopaedic and traumatological traction instruments, reusable
Class I
L091399 - Orthopaedic surgery forceps, reusable – other
Class I
L090901 - Bone cutters, reusable
Class I
L090999 - Orthopaedic surgery cutting instruments, reusable – other
Class I
L091302 - Bone rongeurs, reusable
Class I
L090401 - Orthopaedic surgery osteotomes, reusable
Class I
L091202 - Orthopaedic surgery files, reusable
Class I
L031310 - Dissection forceps, reusable
Class I
L0902 - Orthopaedic surgery levers, reusable
Class I
L091002 - Instruments for processing materials for osteosynthesis, reusable
Class I
L091201 - Orthopaedic surgery rasps, reusable
Class I
L010103 - Handles for scalpels, reusable
Class I
L0102 - Surgical knives, reusable
Class I
L01041299 - Orthopaedic surgery scissors, reusable – other
Class I

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