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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

Calmogel — Class IIb MDD by TAISSIS CONCEPT S.R.L.

MD Atlas
TAISSIS CONCEPT S.R.L.

EUDAMED last updated this device on May 30, 2024

Calmogel

B-05944729006958

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: TAISSIS CONCEPT S.R.L.
UDI-DI code: 05944729006958
Reference / catalog number: C3.640GM

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View device family (Basic UDI)

Manufacturer information

Organization name: TAISSIS CONCEPT S.R.L.
SRN: RO-MF-000001273
Manufacturer status: —

Related devices

CalmogelB-05944729007009On the market CalmogelB-05944729006965On the market CalmogelB-05944729006941On the market CalmogelB-05944729007023On the market CalmogelB-05944729007047On the market

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW030
The use of products is restricted only to practitioners (doctors, paramedics, first aid personnel
CW135
The product should be kept away from children and pets.

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Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Apr 15, 2015	May 30, 2024

Device identification

Trade name: Calmogel
UDI-DI code: 05944729006958
Basic UDI-DI: B-05944729006958
Reference / catalog number: C3.640GM
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Compresse stérile imprégnée pour brûlures, 40 cm x 60 cm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 40 cm x 60 cm

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05944729006958

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EMDN nomenclature code(s)

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

M0408DRESSINGS FOR BURNS ONLY

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.