Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

H007 — Class I MDR by Substrate HD

MD Atlas
Substrate HD

EUDAMED last updated this device on Apr 13, 2024

H007

3770019196H007TF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Substrate HD
UDI-DI code: 03770019196052
Reference / catalog number: H007

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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: 03770019196052
Basic UDI-DI: 3770019196H007TF
Reference / catalog number: H007
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

H0053770019196H005TBOn 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.