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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

DENTAPEN Finger grips spix — Class I MDR by Juvaplus SA

MD Atlas
Juvaplus SA

EUDAMED last updated this device on Apr 28, 2022

DENTAPEN Finger grips spix

++EJUVDP04CC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Juvaplus SA
UDI-DI code: *+EJUVDP041/$$7XXXXXXZ*
Reference / catalog number: DP04

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Manufacturer information

Organization name: Juvaplus SA
SRN: CH-MF-000017503
Manufacturer status: Active

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.

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

Device identification

Trade name: DENTAPEN Finger grips spix
UDI-DI code: *+EJUVDP041/$$7XXXXXXZ*
Basic UDI-DI: ++EJUVDP04CC
Reference / catalog number: DP04
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: 5
Additional product description: A finger grip spix use to connect DENTAPEN with the cartridge holder, and to activate DENTAPEN. It mimics the standard mechanical anaesthesia syringe ergonomics. The spine spix finger grip facilitates certain injections
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

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.

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