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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

FM00160 — Class I MDR by Avery Dennison Medical

MD Atlas
Avery Dennison Medical

EUDAMED last updated this device on Jun 11, 2024

FM00160

081713801TF014XX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Avery Dennison Medical
UDI-DI code: 00817138012269
Reference / catalog number: FM00160

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Manufacturer information

Organization name: Avery Dennison Medical
SRN: IE-MF-000001926
Manufacturer status: Active

Critical warnings

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

CW999
For external use only, Do not apply to cuts or open wounds, Contains alcohol, May sting slightly when applied, Should skin irritation occur, contact your doctor or another health professional

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: not provided
UDI-DI code: 00817138012269
Basic UDI-DI: 081713801TF014XX
Reference / catalog number: FM00160
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: Peristomal Paste, 60g Tube
Additional information URL: https://medical.averydennison.com/en/home/products/finished-goods/eIFUs.html
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

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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.