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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

630446 — Class I MDR by SIA FARMEKO

MD Atlas
SIA FARMEKO

EUDAMED last updated this device on May 23, 2025

630446

475101163PALAGS46

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SIA FARMEKO
UDI-DI code: 04751011630446
Reference / catalog number: 630446

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View device family (Basic UDI)

Manufacturer information

Organization name: SIA FARMEKO
SRN: LV-MF-000007884
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Latvia; available across 1 country total.

Country	On market since	Until
LatviaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04751011630446
Basic UDI-DI: 475101163PALAGS46
Reference / catalog number: 630446
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: The underpad is designed for the care of patients with incontinence – it is used as an additional protective layer in areas where leakage (urine or other fluids) may occur. It can also be used for the care of other patients, including children and newborns. The underpad is placed on a bed or chair, and its absorbent material soaks up moisture, protecting the patient’s skin from irritation and ensuring a dry surface on the bed or chair.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 90 cm X 60 cm, 30 pcs.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04751011630446

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

T04010201UNTUCKABLE UNDERPADS

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

630460475101163PALAGS46On the market 630453475101163PALAGS46On 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.