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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

OFA-OB-120 — Class I MDR by Ostoform Limited

MD Atlas
Ostoform Limited

EUDAMED last updated this device on Apr 20, 2026

OFA-OB-120

539153622OFA-OB8C

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ostoform Limited
UDI-DI code: 05391536221164
Reference / catalog number: OFA-OB-120

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Manufacturer information

Organization name: Ostoform Limited
SRN: IE-MF-000014357
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Dec 17, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05391536221164
Basic UDI-DI: 539153622OFA-OB8C
Reference / catalog number: OFA-OB-120
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: 10
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 120cm/47 ''

EMDN nomenclature code(s)

A108006ABDOMINAL OSTOMY SUPPORT BELTS

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.