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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

OT0164 — Class I MDR by OT Bioelettronica srl

MD Atlas
OT Bioelettronica srl

EUDAMED last updated this device on May 8, 2023

OT0164

805697785BRUXP003PN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OT Bioelettronica srl
UDI-DI code: 08056977850089
Reference / catalog number: OT0164

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View device family (Basic UDI)

Manufacturer information

Organization name: OT Bioelettronica srl
SRN: IT-MF-000033348
Manufacturer status: Active

Related devices

OT0098805697785ADACTPAS00539On the market OT0226805697785ADACTPAS00539On the market OT0228805697785ADACTPAS00539On the market OT0013805697785ADACTPAS00539On the market OT0014805697785ADACTPAS00539On 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.

Critical warnings

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

CW014
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08056977850089
Basic UDI-DI: 805697785BRUXP003PN
Reference / catalog number: OT0164
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: Bruxism monitor device
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

Z12100701EMG TELEMETRY SYSTEMS

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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