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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

0616B5 — Class I MDR by Calzificio Pinelli Srl

MD Atlas
Calzificio Pinelli Srl

EUDAMED last updated this device on May 29, 2026

0616B5

83004960080DDYU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Calzificio Pinelli Srl
UDI-DI code: 08300496070573
Reference / catalog number: 0616B5

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Manufacturer information

Organization name: Calzificio Pinelli Srl
SRN: IT-MF-000005917
Manufacturer status: Active

Critical warnings

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

CW030
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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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: 08300496070573
Basic UDI-DI: 83004960080DDYU
Reference / catalog number: 0616B5
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: Colour Currant - size 2M-XL - Micro-massaging leggings with open toe and 15/21 mmHg graduated compression. Exceptionally elastic, they adhere perfectly to the body for an excellent comfort. Particularly opaque, ideal to be worn outside. The special three-dimensional wave fabric performs a beneficial micromassage that stimulates the microcirculation and helps eliminate excess fluids through the diuresis. Breathable, it prevents the onset of bad odours. Made of a yarn containing a mineral additive FIR (Far Infrared Rays) that stimulates the body natural thermal energy, converts it into infrared rays and sends it back to the skin tissue with a pleasant temperature-control effect. Thighs, buttocks and abdomen improve in tone and appearance. With gusset and flat seams. With antimicrobial treatment. The device is intended for the management and alleviation of the venous and lymphatic return to prevent one or more disorders of circulation (e.g. oedema, deep vein thrombosis (DVT), varicosis, lymphedema)and in case of lipedema. The device is intended as an aid in the treatment of orange peel appearance (cellulite) and during daily and sports activities.
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
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Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

M030499ELASTIC BANDAGES, SUPPORT AND COMPRESSION - 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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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.