Stryker Instruments

Certificate HZ 2247538-1

Rev. 18Supplemented

Valid until: Feb 27, 2031

Certificate HZ 2247538-1 is a valid Quality management system issued to Stryker Instruments and registered in EUDAMED. Valid until February 27, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2247538-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2247538-118

Validity

Issued: May 12, 2026
Valid from: May 12, 2026
Valid until: Feb 27, 2031

Manufacturer

Manufacturer
Manufacturer SRN: US-MF-000025219
Manufacturer country: United States

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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

HZ 2247538-1Quality management systemReissuedFeb 23, 2026 → Feb 27, 2031

Scope coverage

Class IIa19Class I12Class III3Class IIb3

36 scopes

A0380 - Tubular Devices - Accessories
Class I
C900103 - Percutaneous Arterial Access Haemostasis Systems
Class I
M040406 - Polyurethane Dressings
Class I
P099002 - Orthopaedic Cement Preparation and Application Devices and Kits
Class IIIClass I
Q030499 - Otology Devices - Others
Class I
T0204 - Surgical Gowns (Excluding Personal Protective Equipment - PPE)
Class I
T020699 - Medical Use Face Masks (Excluding Personal Protective Equipment - PPE) - Other
Class I
H900102 - Bandages for Sutures
Class I
Z121390 - Various Orthopaedic and Traumatology Instruments
Class I
Z120190 - Various Instruments for General and Multidisciplinary Surgery
Class I
Z120114 - Surgery Navigation Instruments
Class I
K020101 - Mono - and Bipolar Surgical Instruments, single-use
Class I
K020201 - Ultrasonic Surgery Instruments, Single-Use
Class IIa
P090880 - Hip Prosthesis - Accessories
Class IIa
P099002 - Orthopaedic Cement Preparation and Application Devices and Kits
Class IIa
Q010501 - Dental Burs and Abrasive Disks, Single-Use
Class IIa
V0103 - Blades, Single-Use - Not Included in Other Classes
Class IIa
V0199 - Cutting Devices, Single-Use - Other
Class IIa
Z120190 - Various Instruments for General and Multidisciplinary Surgery
Class IIa
Z120590 - Various Instruments for Cardiology and Cardiac Surgery
Class IIa

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