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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

BP_SPRAY100 — Class I MDR by Synkotech Biocompatible…

MD Atlas
Synkotech Biocompatible Materials S.L

EUDAMED last updated this device on Apr 15, 2026

BP_SPRAY100

8437025406BPG6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Synkotech Biocompatible Materials S.L
UDI-DI code: 08437025406104
Reference / catalog number: BP_SPRAY100

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Manufacturer information

Organization name: Synkotech Biocompatible Materials S.L
SRN: ES-MF-000031010
Manufacturer status: Active

Critical warnings

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

CW135
Keep out of reach of children.
CW010
Do not apply in or around the eyes or on mucous membranes. Do not apply in case of allergy to any of its components. Do not apply directly on deep, open, bleeding, or chronic wounds (persistent or non-healing wounds). In case of significant wounds or severely damaged skin, cover the area before applying the product so that it is only dispersed on the perilesional skin. Do not apply on infected areas. Avoid application on heavily macerated skin, open wounds, or severely damaged skin. The product may be applied on slightly macerated skin, but it may cause a temporary stinging or burning sensation during solvent evaporation.
CW007
Do not use if package is damaged
CW057
Highly flammable liquid and vapOUR
CW262
Single patient multiple use

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Sep 21, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437025406104
Basic UDI-DI: 8437025406BPG6
Reference / catalog number: BP_SPRAY100
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: Skin Barrier Film
Additional information URL: https://synkotechbio.com/es/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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

Related devices

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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.