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Organization name
UDI-DI code
Reference / catalog number

Kaptoflat drops and spray — Class IIb MDR by S.I.I.T. srl

MD Atlas
S.I.I.T. srl

EUDAMED last updated this device on May 11, 2026

Kaptoflat drops and spray

805759247BC16DK

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: S.I.I.T. srl
UDI-DI code: 08057592470539
Reference / catalog number: BC16A and BC16B

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View device family (Basic UDI)

Manufacturer information

Organization name: S.I.I.T. srl
SRN: IT-MF-000022188
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

065-00-01-MDRSupplemented
Quality management systemNotified body: 0426Expiry: Nov 20, 2029

Critical warnings

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

CW010
.

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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: Kaptoflat drops and spray
UDI-DI code: 08057592470539
Basic UDI-DI: 805759247BC16DK
Reference / catalog number: BC16A and BC16B
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Kaptoflat drops and spray is a medical device intended for the treatment of infant colics. It is composed of simethicone, an antifoaming agent, emulsified in an oily solution (olive oil).
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.

G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS

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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