Heyer Medical AG

Germany DE-MF-000014330 Last updated 21 Oct 2026 Part of HEYER Medical Co., Ltd.

Devices: 25
Registries: EUDAMED
FDA recalls: 0

Catalogue25

Hyrespira 5-in-1 Rapid Test Ref 140004

Class C EUDAMED Active
Hyrespira 5-in-1 Rapid Test Ref 140003

Class C EUDAMED Active
Hyrespira 5-in-1 Rapid Test Ref 140006

Class C EUDAMED Active
Hyrespira 5-in-1 Rapid Test Ref 140005

Class C EUDAMED Active
Mesh Nebulizer Ref 171001

Class IIa EUDAMED Active
Pasithec II Ref 112000

Class IIb EUDAMED Active
Luvar Ii Ref 122008

Class IIa EUDAMED Active
Port+ Ref H131001

Class IIb EUDAMED Active
Port+ Ref H131002

Class IIb EUDAMED Active
Luvar Ii Ref 122009

Class IIa EUDAMED Active
Luvar Ii Ref 122002

Class IIa EUDAMED Active
Pasithec Ref 111000

Class IIb EUDAMED Active
Luvar Ii Ref 122001

Class IIa EUDAMED Active
Luvar Ii Ref 122011

Class IIa EUDAMED Active
Mesh Nebulizer Ref 171002

Class IIa EUDAMED Active
Luvar Ii Ref 122010

Class IIa EUDAMED Active
Luvar Ii Ref 122005

Class IIa EUDAMED Active
Luvar Ii Ref 122004

Class IIa EUDAMED Active
Port+ Ref H131000

Class IIb EUDAMED Active
Luvar Ii Ref 122006

Class IIa EUDAMED Active
Port+ Ref H131003

Class IIb EUDAMED Active
Luvar Ii Ref 122007

Class IIa EUDAMED Active
Luvar Ii Ref 122003

Class IIa EUDAMED Active
Luvar Sta Ref 121200

Class IIa EUDAMED Active
Luvar A Ref 121100

Class IIa EUDAMED Active

EUDAMED certificates4

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

Notified body 3018 2 certificates

EU-QMS-FI-88700-800168-2026 Issued

Quality management system EU IVDR

Issued
14 Jul 2026

Expires
14 Jul 2031
EU-TDA-FI-92091-800168-2026 Issued

Technical documentation EU IVDR

Issued
14 Jul 2026

Expires
14 Jul 2031

TÜV SÜD Product Service GmbH 0123 2 certificates

G15 108227 0002 Supplemented

Quality management system EU MDR

Issued
28 Sep 2026

Expires
1 Mar 2028

Reason
Add device or group
G15 108227 0004 Issued

Quality management system EU MDR

Issued
8 Oct 2026

Expires
1 Mar 2028

Notified bodies

Notified body 3018
TÜV SÜD Product Service GmbH 0123

About

heyer medical Heyer Medical is a professional manufacturer and supplier of high-quality surgical, emergency and hospital medical devices. We provide global medical equipment supply, distributor cooperation and international exhibition booth services, committed to delivering reliable medical solutions for worldwide medical institutions.

From the manufacturer's own website. Source

Information

Country: Germany(from SRN)
Address: 73, Hagenower Str., Schwerin, Germany
Website: www.heyermedical.de
Email: [email protected]
PRRC contact: Yantao Xiang
EUDAMED SRN: DE-MF-000014330

Catalogue25

Hyrespira 5-in-1 Rapid Test Ref 140004

Hyrespira 5-in-1 Rapid Test Ref 140003

Hyrespira 5-in-1 Rapid Test Ref 140006

Hyrespira 5-in-1 Rapid Test Ref 140005

Mesh Nebulizer Ref 171001

Pasithec II Ref 112000

Luvar Ii Ref 122008

Port+ Ref H131001

Port+ Ref H131002

Luvar Ii Ref 122009

Luvar Ii Ref 122002

Pasithec Ref 111000

Luvar Ii Ref 122001

Luvar Ii Ref 122011

Mesh Nebulizer Ref 171002

Luvar Ii Ref 122010

Luvar Ii Ref 122005

Luvar Ii Ref 122004

Port+ Ref H131000

Luvar Ii Ref 122006

Port+ Ref H131003

Luvar Ii Ref 122007

Luvar Ii Ref 122003

Luvar Sta Ref 121200

Luvar A Ref 121100

EUDAMED certificates4

Notified body 3018 ·2 certificates

TÜV SÜD Product Service GmbH 0123 ·2 certificates

Related companies

Notified bodies

About

Information

Notified body 3018 2 certificates

TÜV SÜD Product Service GmbH 0123 2 certificates