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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

BUB200 — Class I MDR by Arterya

MD Atlas
Arterya

EUDAMED last updated this device on Jan 13, 2026

BUB200

3770040908BUBELT3K

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Arterya
UDI-DI code: 03770040908013
Reference / catalog number: BUB200

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Manufacturer information

Organization name: Arterya
SRN: FR-MF-000037625
Manufacturer status: Active

Critical warnings

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

CW999
BUBELT is contraindicated in patients with a known hypersensitivity to thermoplastic elastomers (TPEs).
CW999
The use of BUBELT is contraindicated on non-intact skin (lesions, wounds, irritations), in order to prevent aggravation of symptoms and to ensure safety of use.
CW999
BUBELT is strictly reserved for use in adults. Use in children and neonates is contraindicated due to skin sensitivity and increased risk of complications.
CW999
In the event of an allergic reaction when using BUBELT, the device should be removed immediately and a healthcare professional should be consulted.

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 03770040908013
Basic UDI-DI: 3770040908BUBELT3K
Reference / catalog number: BUB200
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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

BUL3003770040908BULINK5ZOn the market

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.