Ningbo Xinwell Medical Technology Co., Ltd

Certificate HZ 2114114-1

Rev. Rev.5Supplemented

Valid until: Sep 29, 2026

Certificate HZ 2114114-1 — a Quality management system issued to Ningbo Xinwell Medical Technology Co., Ltd — is approaching its expiry. Valid until September 29, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2114114-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 4
Certificate ID: 0197HZ 2114114-1Rev.5

Validity

Issued: Jan 19, 2026
Valid from: Jan 19, 2026
Valid until: Sep 29, 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: 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

HZ 2114114-1Quality management systemSupplementedDec 30, 2025 → Sep 29, 2026

Scope coverage

Class IIa2Class I1Class IIb1

4 scopes

A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE
Class I
A060101 - VACUUM AND GRAVITY DRAINAGE SYSTEMS G030501 - DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES A010201 - NEEDLES AND KITS - HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE G030499 - ERCP AND SPHINCTEROTOMY DEVICES - OTHER U0601 - UROLOGICAL GUIDEWIRES, HYDROPHILIC U0602 - UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC
Class IIa
R030101 - VENTILATION MASKS R040199 - VENTILATION FILTERS - OTHER R050102 - CLOSED-CIRCUIT RESPIRATORY SUCTION AND IRRIGATION SYSTEMS (NON-ENDOSCOPIC) A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE A010101 - HYPODERMIC NEEDLES G030101 - GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS Z120207 - GENITOURINARY ENDOSCOPY INSTRUMENTS
Class IIa
G030402 - ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND SPHINCTEROTOMY DEVICES PAPILLOTOMES / SPHINCTEROTOMES
Class IIb

Documents

LanguagesEN

Scope coverage

Class IIa2Class I1Class IIb1

4 scopes

A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE
Class I
A060101 - VACUUM AND GRAVITY DRAINAGE SYSTEMS G030501 - DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES A010201 - NEEDLES AND KITS - HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE G030499 - ERCP AND SPHINCTEROTOMY DEVICES - OTHER U0601 - UROLOGICAL GUIDEWIRES, HYDROPHILIC U0602 - UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC
Class IIa
R030101 - VENTILATION MASKS R040199 - VENTILATION FILTERS - OTHER R050102 - CLOSED-CIRCUIT RESPIRATORY SUCTION AND IRRIGATION SYSTEMS (NON-ENDOSCOPIC) A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE A010101 - HYPODERMIC NEEDLES G030101 - GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS Z120207 - GENITOURINARY ENDOSCOPY INSTRUMENTS
Class IIa
G030402 - ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND SPHINCTEROTOMY DEVICES PAPILLOTOMES / SPHINCTEROTOMES
Class IIb

Certificate HZ 2114114-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate HZ 2114114-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer