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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

BABY SENSORIZED TEXTILE UNIT SIZE 2 — Class I MDR by ComfTech

MD Atlas
ComfTech

EUDAMED last updated this device on Aug 27, 2025

BABY SENSORIZED TEXTILE UNIT SIZE 2

805361020TEXTILEHBHS55

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ComfTech
UDI-DI code: 08053610200058
Reference / catalog number: CMF9TXM10

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View device family (Basic UDI)

Manufacturer information

Organization name: ComfTech
SRN: IT-MF-000028032
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

ITH 1342906 1Issued
Quality management systemNotified body: 1936Expiry: Nov 25, 2029

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW999
Device cannot be used and worn by anyone who is or might be allergic to cotton or silver
CW999
The device has to be used on intact skin

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Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: BABY SENSORIZED TEXTILE UNIT SIZE 2
UDI-DI code: 08053610200058
Basic UDI-DI: 805361020TEXTILEHBHS55
Reference / catalog number: CMF9TXM10
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: —
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

UDI-DI DataMatrix

Encoded

(01)08053610200058

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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.

Z12030280VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES

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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