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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

BAPSCARCARE S 5x20cm — Class I MDR by BAP Medical B.V.

MD Atlas
BAP Medical B.V.

EUDAMED last updated this device on May 9, 2022

BAPSCARCARE S 5x20cm

5425013001335PY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BAP Medical B.V.
UDI-DI code: 05425013000345
Reference / catalog number: 60S-0520

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View device family (Basic UDI)

Manufacturer information

Organization name: BAP Medical B.V.
SRN: NL-MF-000002030
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

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	May 16, 2013	Still on market

Device identification

Trade name: BAPSCARCARE S 5x20cm
UDI-DI code: 05425013000345
Basic UDI-DI: 5425013001335PY
Reference / catalog number: 60S-0520
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: 2
Additional product description: Medical silicone sheets for treating scars (hypertrophic and keloid) and preventing abnormal scar development after surgery or injury. Self-adhesive, thick, washable, transparent and can be used for long periods.
Additional information URL: https://www.bap-medical.com/brands/bapscarcare/
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

Encoded

(01)05425013000345

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

M04040701SILICONE DRESSINGS, NON-COMBINED

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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