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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

Citoplast Comfort — Class I MDR by Sopharma AD

MD Atlas
Sopharma AD

EUDAMED last updated this device on Aug 9, 2022

Citoplast Comfort

3800010632003293

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sopharma AD
UDI-DI code: 03800010647458
Reference / catalog number: 32003000-0056

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Manufacturer information

Organization name: Sopharma AD
SRN: BG-MF-000019983
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

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

CW009
Re-use of the product is not allowed as it may cause infection.
CW011
Change daily.

Market distribution

Primary placement in Bulgaria; available across 1 country total.

Country	On market since	Until
BulgariaPrimary placement	May 21, 2021	Jul 12, 2024

Device identification

Trade name: Citoplast Comfort
UDI-DI code: 03800010647458
Basic UDI-DI: 3800010632003293
Reference / catalog number: 32003000-0056
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: 16
Additional product description: Citoplast Comfort (Elastic / Waterproof), Mix 4 sizes: - 2 pcs. (φ 25 mm); - 2 pcs. (29 mm x 56 mm); - 8 pcs. (19 mm x 72 mm); - 4 pcs. (30 mm x 72 mm);
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M04010102POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD

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
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Software identification