Hantech Medical Device Co., Ltd.

China CN-MF-000016465 Last updated 25 Oct 2026

Devices: 20
Registries: EUDAMEDFDA 510(k)FDA
FDA recalls: 0

Catalogue20

Infusion sets for single use with pressure infusion apparatus (Without Needle)(Infusion Sets with Light Resistant Function) Ref S-PL-005DN

Class IIa EUDAMED Active
Infusion sets for single use with pressure infusion apparatus (Without Needle)(Infusion Sets with Light Resistant Function) Ref S-PL-003DN

Class IIa EUDAMED Active
Administration Set Ref PCA02002

Class IIa EUDAMED Active
Administration Set Ref GEN02012

Class IIa EUDAMED Active
Administration Set Ref GEN03012

Class IIa EUDAMED Active
Micro-Fine™ Insulin Syringes Ref 0.5ml 0.25×8mm U-100

Class IIa EUDAMED Active
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) Ref K231363

Class II FDA 510(k) Active
Disposable Medical Safety Hypodermic Needle Ref K220603

Class II FDA 510(k) Active
Disposable Medical Masks Ref K221038

Class II FDA 510(k) Active
Disposable Insulin Pen Needle Ref K222739

Class II FDA 510(k) Active
Disposable Insulin Syringe Ref K222672

Class II FDA 510(k) Active
Umbilical Cord Clamp Ref 2002

Class I EUDAMED Active
Micro-Fine™ Insulin Syringes Ref 1ml 0.25×8mm U-100

Class IIa EUDAMED Active
Umbilical Cord Clamp Ref 2001

Class I EUDAMED Active
Amniotic Membrane Perforators Ref 1001

Class IIa EUDAMED Active
Umbilical cord clamp clipper Ref 3001

Class I EUDAMED Active
Administration Set Ref PCA04002

Class IIa EUDAMED Active
Administration Set Ref GEN21002

Class IIa EUDAMED Active
Administration Set Ref GEN01002

Class IIa EUDAMED Active
Administration Set Ref PCA21002

Class IIa EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

TÜV Rheinland LGA Products GmbH 0197 1 certificate

HZ 2620038-1 Issued

Quality management system EU MDR

Issued
30 Sep 2026

Expires
29 Sep 2031

Authorised representatives

Shanghai International Holding Corp. GmbH(Europe) DE

Notified bodies

TÜV Rheinland LGA Products GmbH 0197

Information

Country: China(from SRN)
Address: No. 288, Sanheng Road, Changhe Industrial Park, Cixi, Ningbo, China
Website: hantechmedical.com
Email: [email protected]
PRRC contact: Yang arnold
EUDAMED SRN: CN-MF-000016465
FDA FEI number: 3015060216

Catalogue20

Infusion sets for single use with pressure infusion apparatus (Without Needle)(Infusion Sets with Light Resistant Function) Ref S-PL-005DN

Infusion sets for single use with pressure infusion apparatus (Without Needle)(Infusion Sets with Light Resistant Function) Ref S-PL-003DN

Administration Set Ref PCA02002

Administration Set Ref GEN02012

Administration Set Ref GEN03012

Micro-Fine™ Insulin Syringes Ref 0.5ml 0.25×8mm U-100

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) Ref K231363

Disposable Medical Safety Hypodermic Needle Ref K220603

Disposable Medical Masks Ref K221038

Disposable Insulin Pen Needle Ref K222739

Disposable Insulin Syringe Ref K222672

Umbilical Cord Clamp Ref 2002

Micro-Fine™ Insulin Syringes Ref 1ml 0.25×8mm U-100

Umbilical Cord Clamp Ref 2001

Amniotic Membrane Perforators Ref 1001

Umbilical cord clamp clipper Ref 3001

Administration Set Ref PCA04002

Administration Set Ref GEN21002

Administration Set Ref GEN01002

Administration Set Ref PCA21002

EUDAMED certificates1

TÜV Rheinland LGA Products GmbH 0197 ·1 certificate

Related companies

Authorised representatives

Notified bodies

Information

TÜV Rheinland LGA Products GmbH 0197 1 certificate