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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

JUVAPEN Toxin syringe holder — Class I MDR by Juvaplus SA

MD Atlas
Juvaplus SA

EUDAMED last updated this device on Apr 28, 2022

JUVAPEN Toxin syringe holder

++EJUVJP02DJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Juvaplus SA
UDI-DI code: *+EJUVJP021/$$7XXXXXXZ*
Reference / catalog number: JP02

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Manufacturer information

Organization name: Juvaplus SA
SRN: CH-MF-000017503
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.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Mar 28, 2022	Still on market

Device identification

Trade name: JUVAPEN Toxin syringe holder
UDI-DI code: *+EJUVJP021/$$7XXXXXXZ*
Basic UDI-DI: ++EJUVJP02DJ
Reference / catalog number: JP02
Issuing entity: HIBCC

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 3
Additional product description: The syringe holder is a non-sterile device intended to be used with the Juvapen Toxin powered syringe. The syringe holder makes the link between the syringe and the Juvapen Toxin, and to activate Juvapen Toxin during the local injection of sterile materials (Botulinum Toxin) into human body in accordance with the best judgment of the clinician.
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

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Expiration date
Manufacturing date
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Software identification