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Organization name
UDI-DI code
Reference / catalog number

Armilla® Patient Wristband Stick… — Class I MDR

MD Atlas
Mediaform Informationssysteme GmbH

EUDAMED last updated this device on Jun 13, 2025

Armilla® Patient Wristband Stick TTP Adults

4065825AR920N6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Mediaform Informationssysteme GmbH
UDI-DI code: 04065825001201
Reference / catalog number: 920-460

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Manufacturer information

Organization name: Mediaform Informationssysteme GmbH
SRN: DE-MF-000005335
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW999
Danger in case of swelling: When adjusting the size, make sure there is enough space between wristband and the joint to allow for free movement.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Austria		Still on market

Device identification

Trade name: Armilla® Patient Wristband Stick TTP Adults
UDI-DI code: 04065825001201
Basic UDI-DI: 4065825AR920N6
Reference / catalog number: 920-460
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: 250
Additional product description: In combination with medical devices and software, barcoded Armilla® patient wristbands are used for the secure processing of medical data for therapeutic purposes. They serve to close the closed loop in: medical treatments, parameter monitoring, validation of medication assignment or during surgical procedures .
Additional information URL: https://shop.mediaform.de/etiketten/medizinische-etiketten/patientenarmbaender.html
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

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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.