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

Ostoform Barrier Extender — Class I MDR by Ostoform Limited

MD Atlas
Ostoform Limited

EUDAMED last updated this device on Feb 26, 2026

Ostoform Barrier Extender

539153622OFA-EXTEK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ostoform Limited
UDI-DI code: 05391536221966
Reference / catalog number: OFA-10010

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: 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 Czechia; available across 1 country total.

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

Device identification

Trade name: Ostoform Barrier Extender
UDI-DI code: 05391536221966
Basic UDI-DI: 539153622OFA-EXTEK
Reference / catalog number: OFA-10010
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: 20
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 FLOWASSIST Seal539153622OFAKPOn 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.