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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

Sanplast Delicate — Class I MDR by Sopharma AD

MD Atlas
Sopharma AD

EUDAMED last updated this device on Aug 12, 2022

Sanplast Delicate

380001063200318Z

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sopharma AD
UDI-DI code: 03800728497642
Reference / catalog number: 32003000-0036

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Manufacturer information

Organization name: Sopharma AD
SRN: BG-MF-000019983
Manufacturer status: Active

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.

CW007
The plasters shall not be used when the product is damaged.
CW011
The product shall be kept in dark, cool, dry place.

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: Sanplast Delicate
UDI-DI code: 03800728497642
Basic UDI-DI: 380001063200318Z
Reference / catalog number: 32003000-0036
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: 1
Additional product description: Non-woven paper tape for very sensitive and delicate skin (Breathable) - 2,5 cm / 5 m;
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M050101PLASTERS ON SPOOLS (ROLLS)

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

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