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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

Balneum Intensiv ® 10g (GB) — Class IIa MDD by Polichem SA,…

MD Atlas
Polichem SA, Lussemburgo, succursale di Mendrisio

EUDAMED last updated this device on Jan 11, 2024

Balneum Intensiv ® 10g (GB)

B-08430308132790

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Polichem SA, Lussemburgo, succursale di Mendrisio
UDI-DI code: 08430308132790
Reference / catalog number: 08430308132790

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Manufacturer information

Organization name: Polichem SA, Lussemburgo, succursale di Mendrisio
SRN: CH-MF-000025294
Manufacturer status: Active

Related devices

08430308132806B-08430308132806On the market Balneum Intensiv ® 500g (GB)B-08430308133292On the market Balneum Intensiv ® 50g (GB)B-08430308133308On the market 08430308132905B-08430308132905On the market 08430308133315B-08430308133315On 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
Contraindications: Do not use Balneum Intensiv cream if you are allergic to any of its ingredients, soya or peanut. Precautions: For topical use only. Keep out of the sight and the reach of children. If your condition worsens or you experience any unwanted effects, stop using the cream and discuss with your doctor.

Market distribution

Primary placement in XI; available across 1 country total.

Country	On market since	Until
XIPrimary placement		Still on market

Device identification

Trade name: Balneum Intensiv ® 10g (GB)
UDI-DI code: 08430308132790
Basic UDI-DI: B-08430308132790
Reference / catalog number: 08430308132790
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification