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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

MED PAD 0118 — Class I MDR by Global Health…

MD Atlas
Global Health Technology AS

EUDAMED last updated this device on Apr 26, 2023

MED PAD 0118

709005037STOMAPAD4W

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Global Health Technology AS
UDI-DI code: 07090050370119
Reference / catalog number: MED PAD 0118

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Manufacturer information

Organization name: Global Health Technology AS
SRN: NO-MF-000007974
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Norway; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 07090050370119
Basic UDI-DI: 709005037STOMAPAD4W
Reference / catalog number: MED PAD 0118
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: Erland Care Stoma Pad is a new all in one product that ensures safe and stable attachment of bag and plate. This reduces the risk of leakage under the plate. The superabsorbent pad is affixed directly to the skin and absorbs a high volume of effluent from stoma bags where the adhesive has dissolved.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

A108001RINGS / BEZELS / PLATES FOR PERISTOMAL SKIN
M04010199ADHESIVE DRESSINGS, WITH ABSORBENT PAD - 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

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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.