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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

26109 — Class IIa MDR by TENACTA GROUP S.p.A.

MD Atlas
TENACTA GROUP S.p.A.

EUDAMED last updated this device on Mar 3, 2026

26109

8007403S529S

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TENACTA GROUP S.p.A.
UDI-DI code: 08007403261092
Reference / catalog number: 26109

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View device family (Basic UDI)

Manufacturer information

Organization name: TENACTA GROUP S.p.A.
SRN: IT-MF-000039868
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement		Still on market
Portugal		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08007403261092
Basic UDI-DI: 8007403S529S
Reference / catalog number: 26109
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: faja termica recargable cervical M-L
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: M/L

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08007403261092

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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.

Z12069099VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - 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

261108007403S529SOn the market 261088007403S529SOn the market 260838007403S529SOn the market 260828007403S529SOn the market 260818007403S529SOn the market

Certificates

Certificate health across this manufacturer's portfolio.

263/MDRIssued
Quality management systemNotified body: 0051Expiry: Jan 22, 2031