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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

BOUFFANT cap — Class I MDR by Med Consulting Srl

MD Atlas
Med Consulting Srl

EUDAMED last updated this device on Oct 29, 2024

BOUFFANT cap

805571954BOCAPDD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Med Consulting Srl
UDI-DI code: 08055719543654
Reference / catalog number: BOCAP-BW

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View device family (Basic UDI)

Manufacturer information

Organization name: Med Consulting Srl
SRN: IT-MF-000044315
Manufacturer status: Active

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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.

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: BOUFFANT cap
UDI-DI code: 08055719543654
Basic UDI-DI: 805571954BOCAPDD
Reference / catalog number: BOCAP-BW
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: 100
Additional product description: Breathable, soft, odorless disposable BOUFFANT cap. Good fit with elastic along the entire edge. The product is made of water-repellent polypropylene TNT (10 gsm), free of resins, glues and glass fibres. The elastic is made of rubber covered with cotton. The material is hypoallergenic. Latex free. Diameter 210 mm extendable up to 540 mm.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: White / Bianco

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08055719543654

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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.

T0399PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - 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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