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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

K46 — Class I MDR by PHYTO PERFORMANCE…

MD Atlas
PHYTO PERFORMANCE ITALIA SRL

EUDAMED last updated this device on Apr 15, 2026

K46

80312550012JR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PHYTO PERFORMANCE ITALIA SRL
UDI-DI code: 08031255021795
Reference / catalog number: K46

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View device family (Basic UDI)

Manufacturer information

Organization name: PHYTO PERFORMANCE ITALIA SRL
SRN: IT-MF-000008118
Manufacturer status: Active

Related devices

HOT-COLD BAND CM 15X53 + CRYOFLEX80312550009K4On the market K-PH/30/ROSSO80312550013JTOn the market K-PH/1BLUE80312550013JTOn the market K-PH/1ORANGE80312550013JTOn the market NEOPRENE HINGED KNEE BRACE - M80312550009K4On 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.

Critical warnings

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

CW999
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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08031255021795
Basic UDI-DI: 80312550012JR
Reference / catalog number: K46
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: BENDA ELASTICA
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.

M0303010101ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION

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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