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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

522013 — Class I MDR by IVF HARTMANN AG

MD Atlas
IVF HARTMANN AG

EUDAMED last updated this device on Mar 25, 2026

522013

76116001083M4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: IVF HARTMANN AG
UDI-DI code: 07611600996865
Reference / catalog number: 522013

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Manufacturer information

Organization name: IVF HARTMANN AG
SRN: CH-MF-000015962
Manufacturer status: Active

Critical warnings

6 warnings recorded — scroll inside the panel to see all entries.

CW999
Not to be used in case of hypersensitivity against one of the ingredients.
CW999
Product not to be used on open wounds and/or abrasions or close to mucous membranes and in eyes.
CW999
Do not use on children under 3 years of age!
CW999
Do not use during pregnancy or while breastfeeding.
CW999
Inflammable!
CW011
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Belgium; available across 3 countries total.

Country	On market since	Until
BelgiumPrimary placement		Still on market
Austria		Still on market
Germany		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07611600996865
Basic UDI-DI: 76116001083M4
Reference / catalog number: 522013
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: SELF-COOLING SUPPORT BANDAGE
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 400 MU10
6 MU10

EMDN nomenclature code(s)

M03040299ELASTIC SUPPORT BANDAGES - 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

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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.