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Organization name
UDI-DI code
Reference / catalog number

BIOFAMILY HOT-COLD BAND — Class I MDR by PHYTO PERFORMANCE…

MD Atlas
PHYTO PERFORMANCE ITALIA SRL

EUDAMED last updated this device on May 25, 2026

BIOFAMILY HOT-COLD BAND

80312550009K4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PHYTO PERFORMANCE ITALIA SRL
UDI-DI code: 08013366000197
Reference / catalog number: BF0017

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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
Neoprene may cause allergic reactions of the skin. If rash develops discontinue use and consult a physician. In case of circulatory problems use it under medical supervision. Do not use the band while sleeping.

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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: BIOFAMILY HOT-COLD BAND
UDI-DI code: 08013366000197
Basic UDI-DI: 80312550009K4
Reference / catalog number: BF0017
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: Adjustable band to place and fix to the body the reusable cold/hot gel or instant cold pack. With elastic band. The packaging contains the neoprene band. One size. How to apply: 1. insert the pad in the internal pocket. 2. verify that cold or hot don't cause any frostbite or burn respectively. 3. fasten the elastic strap to have a comfortable fit.
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.

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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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