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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

H005 — Class I MDR by Substrate HD

MD Atlas
Substrate HD

EUDAMED last updated this device on Apr 13, 2024

H005

3770019196H005TB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Substrate HD
UDI-DI code: 03770019196045
Reference / catalog number: H005

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Manufacturer information

Organization name: Substrate HD
SRN: FR-MF-000000507
Manufacturer status: Active

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Germany		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03770019196045
Basic UDI-DI: 3770019196H005TB
Reference / catalog number: H005
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 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: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1205078099INSTRUMENTS FOR CARDIOLOGICAL POLYGRAPHY - HARDWARE ACCESSORIES - OTHER

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

Related devices

H0073770019196H007TFOn the market Volta AF-Xplorer3770019196A002RLOn the market A0033770019196A003RNOn the market

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.