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Organization name
UDI-DI code
Reference / catalog number

BM004 — Class I MDD by Curtis Health Caps S.A.

MD Atlas
Curtis Health Caps S.A.

EUDAMED last updated this device on Aug 26, 2022

BM004

B-BM004RM

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Curtis Health Caps S.A.
UDI-DI code: D-BM004RM
Reference / catalog number: BM004

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View device family (Basic UDI)

Manufacturer information

Organization name: Curtis Health Caps S.A.
SRN: PL-MF-000007127
Manufacturer status: Active

Critical warnings

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

CW275
The product can be used by pregnant women and during breastfeeding after consulting a doctor. The use of the product in children under 1 year of age should be consulted with a doctor. If in doubt, contact your doctor or pharmacist.
CW010
Use only in accordance with the instructions for use.
CW277
If symptoms persist or worsen after 7 days, consult your doctor or pharmacist.
CW135
Keep out of the reach and sight of children.
CW011
Due to the content of sucrose (810 mg/ 5ml) caution is recommended in diabetic patients. May have a laxative effect if used too much in children. Do not use in case of allergy or hypersensitivity to any of the ingredients of the product.

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Market distribution

Primary placement in Poland; available across 2 countries total.

Country	On market since	Until
PolandPrimary placement	May 19, 2021	Still on market
Slovakia	May 19, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-BM004RM
Basic UDI-DI: B-BM004RM
Reference / catalog number: BM004
Issuing entity: EUDAMED

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Icelandic lichen syrup is a medical device used to protect and moisturize the oral mucosa and throat. The medical device soothes the symptoms of dry cough, hoarseness, as well as the feeling of dryness, burning and sore throat. The Icelandic lichen extract contained in the product contain numerous mucilaginous substances forming a protective coating, which reduces the susceptibility to external irritating factors. The content of a coating substance facilitates swallowing and reduces the cough reflex. The medical device can be used as an auxiliary agent during bacterial and viral infections (e.g. colds, angina) as well as after diseases in order to soothe irritation of the oral mucosa and throat.
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

UDI-DI DataMatrix

D-BM004RM

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES

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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Related devices

This device is not currently linked to any other device.

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.