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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

FLOWASSIST Seal — Class I MDR by Ostoform Limited

MD Atlas
Ostoform Limited

EUDAMED last updated this device on Feb 25, 2026

FLOWASSIST Seal

539153622OFAKP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ostoform Limited
UDI-DI code: 05391536220389
Reference / catalog number: OFA-L

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Manufacturer information

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

Critical warnings

2 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.

Market distribution

Primary placement in Ireland; available across 1 country total.

Placed on the market in Ireland; per-country availability dates not published.

Device identification

Trade name: FLOWASSIST Seal
UDI-DI code: 05391536220389
Basic UDI-DI: 539153622OFAKP
Reference / catalog number: OFA-L
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: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A108001RINGS / BEZELS / PLATES FOR PERISTOMAL SKIN

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

FLOWASSIST Seal539153622OFAKPOn the market FLOWASSIST Seal539153622OFAKPOn the market Ostoform Barrier Extender539153622OFA-EXTEKOn the market Ostoform Crest Moldable Barrier539153622A1-BSFMz5GOn the market Ostoform FLOWASSIST Drainable Pouch539153622OFA-DP87On 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.