Diagramm Halbach GmbH & Co. KG

Active in EUDAMED

Germanyfrom SRN EUDAMED SRN DE-MF-000012732

Devices: 193
Registrations: EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union: EUDAMED actor, 1 certificate

What Diagramm Halbach GmbH & Co. KG makes

Diagramm Halbach GmbH & Co. KG manufactures disposable paper rolls and sheets designed for use in cardiotocography (CTG) and electrocardiography (EKG) monitoring systems. Their products include standard-sized paper for continuous ECG recordings, such as 112 mm x 25 m rolls for devices like Fukuda Denshi and Schiller Defigard Touch, as well as pre-cut sheets for CTG printers, including 152 mm x 100 mm packs for systems like GE Corometrics. Additional formats cater to specific devices, such as 130 mm x 50 m rolls for Vyaire (GE) EK33/43 monitors and compact 90 mm x 70 mm x 400-sheet packs for Esaote Biomedica Personal P80 printers.

The company’s products are classified as Class I medical devices under EU regulations and are registered in the eudamed database. Their portfolio is manufactured in Germany and adheres to EU Medical Device Regulation (MDR) requirements for non-invasive diagnostic devices. No additional national or international registries are specified for these items.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue193

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Company details

EUDAMED SRN: DE-MF-000012732
EU VAT number: DE 124 890 890
EUDAMED status: Active
EUDAMED registered name: Diagramm Halbach GmbH & Co. KG
Registered address: 14, Am Winkelstück, 58239, Schwerte, Germany
Email: [email protected]
Phone: +49 2304 7590
PRRC contact: Martin Piela(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 21 Jul 2029

TÜV NORD CERT GmbH 0044 1 certificate

44910230746 Active Supplemented

Quality assurance EU MDR

Issued
28 Apr 2025

Expires
21 Jul 2029

Reason
Add device or group

Frequently asked questions

How many devices does Diagramm Halbach GmbH & Co. KG have in the registry?

The registry currently lists 193 devices for Diagramm Halbach GmbH & Co. KG. Devices recorded under merged duplicate company entries are counted once.

Which registries list Diagramm Halbach GmbH & Co. KG's devices?

Among its 50 most recently registered devices, Diagramm Halbach GmbH & Co. KG has devices listed in EUDAMED (50 devices).

What risk classes do Diagramm Halbach GmbH & Co. KG's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Diagramm Halbach GmbH & Co. KG's devices are Class I. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Diagramm Halbach GmbH & Co. KG?

EUDAMED lists 1 certificate for Diagramm Halbach GmbH & Co. KG (quality assurance) under MDR. The most recent was issued on 28 Apr 2025.

What are the newest devices from Diagramm Halbach GmbH & Co. KG in the registry?

The most recently registered devices listed for Diagramm Halbach GmbH & Co. KG include Clinical Ultraschallgel Blau 5,0 L Cubitainer, Clinical Ultraschallgel Transparant 5,0 L Kanister, Clinical Ultraschallgel Blau 250 ml and Clinical Ultraschallgel Transparent 5,0 L Cubitainer.

Generated automatically from registry data and not verified by a human reviewer.

At a glance

EU certificates

Market reach

What Diagramm Halbach GmbH & Co. KG makes

Catalogue193

Clinical Ultraschallgel Blau 5, 0 L Cubitainer Ref 01000681

Clinical Ultraschallgel Transparant 5, 0 L Kanister Ref 01000679

Clinical Ultraschallgel Blau 250 ml Ref 01000680

Clinical Ultraschallgel Transparent 5, 0 L Cubitainer Ref 01000678

Clinical Ultraschallgel Transparent 500 ml Ref 01000676

Clinical Ultraschallgel Transparent 250 ml Ref 01000675

Clinical Ultraschallgel Transparent 1, 0 L Flasche Ref 01000677

CTG-Papiere Neoventa STAN P11 152 mm x 100 mm x 150 Bl, zu CNS000005-1 Ref 719920

EKG-Papiere Spacelabs CExpress SE 210 mm x 295 mm x 180 Bl, Original 712180SL12A-SE Ref 690192

EKG-Papiere Fukuda Denshi 112 mm x 25 m, zu ECG-1106 Ref 715092

EKG-Papiere Vyaire (GE) EK33/43 130 mm x 50 m, zu 22606103 Ref 712120

EKG-Papiere Cardioline Delta 30 183 mm x 30 m, zu 874.3555 Ref 714530

EKG-Papiere BCM Serie 600 112 mm x 25 m Ref 715810

EKG-Papiere Schiller Defigard Touch 7 110mm x 40m, zu 214449 Ref 716278

EKG-Papiere Cardiette 134 mm x 25 ml, zu 66010002 Ref 716130

EKG-Papiere Esaote Biomedica Personal P80 90 mm x 70 mm x 400 Bl, zu 9690029000 Ref 716621

EKG-Papiere Physio Control Lifepack 6-10, 20 50 mm x 30 m, zu 804700-010 Ref 716430

EKG-Papiere Vyaire(GE) Cardiosmart, Mac1200, 1600 210 mm x 295 mm x 150 Bl, zu 22616611 Archivist Ref 712760

CTG-Papiere Carefusion (GE Corometrics) 152 mm x 90 mm x 160 Bl, zu 4305AAO/CAO Ref 719615

EKG-Papier Faltpapier zu ° EPR 600/1000/ ICS 3000 Biotronik 111 mm x 125 mm x 200 Bl Ref 726400

EKG-Papiere Edan SE12 210 mm x 295 mm x 200 Bl, zu MS1-32642 Ref 713820

EKG-Papiere Nihon Kohden Lifescope 50 mm x 100 mm x 300 Bl, zu FQW50-3-100 Ref 716518

EKG-Papiere Nihon Kohden 9110/9130 210 mm x 140 mm x 210 Bl, zu FQW210-3-140 Ref 727030

CTG-Papiere HNE Healthcare Baby Doplex 3000 151 mm x 150 mm x 150 Bl, zu 2930 Ref 721000

EKG-Papiere Cardiette AR1200 120 mm x 100 mm x 300 Bl, zu 66010039 Ref 716139

EKG-Papiere Custo-med 210 mm x 150 mm x 250 Bl, zu 22012/22014 Ref 716720

EKG-Papiere Cardisuny IC501AX/BX/DX 63 mm x 100 mm x 500 Bl, zu 08.420.01 Ref 714980

EKG-Papiere Guidant 110 mm x 75 mm x 400 Bl, zu CPI2910 Ref 716830

EKG-Papiere Metrax Primedic Defi EVO 80 mm x 80mm x 200 Bl, Ref 716438

EKG-Papiere Spacelabs Edan 210 mm x 295 mm x 180 Bl, Original 712180SL12A Ref 690191

EKG-Papiere Cardiette Start 200 210 mm x 20 m, zu 66010029 Ref 716126

EKG-Papiere Bosch EKG601 63 mm x 30 m, zu 6786771007 Ref 714610

EKG-Papiere Cardioline Delta 60 Plus 210 mm x 30 m, zu 874.3556 Ref 714570

EKG-Papiere Fukuda Denshi 145 mm x 30 m, zu FCP145 Ref 715030

EKG-Papiere Hörmann Bioset 8000 210 mm x 50 m, zu 2100-000-020 Ref 725080

EKG-Papiere Fukuda Denshi FX3010 145 mm x 75 mm x 267 Bl, zu OP382TE Ref 715040

EKG-Papiere Biocare iE12A 210 mm x 150 mm x 140 Bl. Ref 714571

EKG-Papiere Bosch EK 13A/103A/103L 145 mm x 50 m, zu 6786753145 Ref 714640

EKG-Papiere Fukuda Denshi CardioMax FX7402, FX7542 210 mm x 300 mm x 340 Bl, zu OP-621TE Ref 650267

EKG-Papiere Cardioline ETA 125/340 125 mm x 30 m, zu 874.3503 Ref 714460

EKG-Papiere Hörmann Bioset 3500 110 mm x 25 m, zu 2000-000-031 Ref 725020

EKG-Papiere Edan, Mindray DECG-03A, SE3/300 80 mm x 20 m Ref 713800

EKG-Papiere Schiller AT-6/SP-200 145 mm x 100 mm x 260 Bl, zu 2.157005 / 290051 Ref 706290

EKG-Papiere Cardioline Delta 1 Plus 60 mm x 28 m, zu 874.3560 Ref 714560

EKG-Papiere Welch Allyn CP50 114 mm x 70 mm x 250 Bl, zu 406021 Ref 715940

EKG-Papiere Burdick 210 mm x 300 mm x 200 Bl, zu 007985 Ref 715776

EKG-Papiere Mindray R 12 Beneheart 210mm x 295 mm x 100 Bl Ref 713815

EKG-Papiere Cardisuny IC503F/Alpha 600 145 mm x 150 mm x 400 Bl, zu 08.401.05/08.401.09 Ref 714900

EKG-Papiere Siemens Sicard 440 148 mm x 25 m, zu 9390717 Ref 711870

EEG-Papiere Schwarzer ES10000, orange 210 mm x 300 mm x 1000 Bl, zu 1756210 Ref 718350

Company details

EUDAMED certificates1

TÜV NORD CERT GmbH 0044 ·1 certificate

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Certifiers

Frequently asked questions

TÜV NORD CERT GmbH 0044 1 certificate