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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

MANCHE AU COUDE - L — Class I MDR by PHYTO PERFORMANCE…

MD Atlas
PHYTO PERFORMANCE ITALIA SRL

EUDAMED last updated this device on May 28, 2026

MANCHE AU COUDE - L

80312550009K4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PHYTO PERFORMANCE ITALIA SRL
UDI-DI code: 08031255038588
Reference / catalog number: P3013/L

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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
If you feel itching, do not use the product and consult a doctor. In case of circulatory problems, use under medical supervision. Do not use for sleeping. To be used under the supervision of an adult for children under 14 years of age.

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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: MANCHE AU COUDE - L
UDI-DI code: 08031255038588
Basic UDI-DI: 80312550009K4
Reference / catalog number: P3013/L
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 elbow brace/sleeve is indicated in case of sprains and muscle strains, relieves pain thanks to the compression exerted, useful during sports activities to support and protect the elbow. Washing instructions: After each use, hand wash in cold water with mild soap or detergent. Allow to dry completely. Do not tumble dry or iron. Warning: the user is required to report any incident and/or serious incident that may occur in relation to the device both to the manufacturer and to the competent authority of the Member State in which the user and/or patient is established. The shelf life of this medical device depends on the frequency of use, if used daily it is 2 years.
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.

Y090612ARM AND ELBOW PROTECTIONS

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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