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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

H131002 — Class IIb MDD by Heyer Medical AG

MD Atlas
Heyer Medical AG

EUDAMED last updated this device on Mar 16, 2026

H131002

B-04251743800105

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Heyer Medical AG
UDI-DI code: 04251743800105
Reference / catalog number: H131002

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Manufacturer information

Organization name: Heyer Medical AG
SRN: DE-MF-000014330
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Aug 19, 2018	Dec 31, 2028

Device identification

Trade name: not provided
UDI-DI code: 04251743800105
Basic UDI-DI: B-04251743800105
Reference / catalog number: H131002
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: The Ventilator is applicable for the patient weighing at least 3.5kg, infant, children and adult patients.

EMDN nomenclature code(s)

Z12030104PORTABLE PULMONARY VENTILATORS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.