Question 1

What does JUVAPLUS SA manufacture?

Accepted Answer

JUVAPLUS SA manufactures reusable dental anaesthesia syringes and associated components, including protective sleeves, battery-powered injectors, cartridge holders, and complete kits for dental procedures. Their portfolio includes standalone devices like the Dentapen Injector and Juvapen Expert, as well as bundled solutions such as the DENTAPEN Pro 2.2ml kit.

Question 2

Where is JUVAPLUS SA based?

Accepted Answer

JUVAPLUS SA is headquartered in Switzerland, as indicated by the country code CH in their device data. The company operates from Switzerland and manufactures dental anaesthesia syringes and related components for dental procedures.

Question 3

Which regulatory registries list JUVAPLUS SA's devices?

Accepted Answer

JUVAPLUS SA's devices are listed in the EUDAMED database, which is the European Union's medical device database, and the FDA's Unique Device Identification (UDI) system. These listings help track and identify the company's dental anaesthesia syringes and components across different regulatory jurisdictions.

Question 4

How are JUVAPLUS SA's devices classified?

Accepted Answer

JUVAPLUS SA's devices are classified under EU Medical Device Regulations as Class I, Class II, and Class IIa. This classification system indicates the level of risk associated with each device, with Class I being the lowest risk and Class IIa being moderate risk, which determines the regulatory requirements each device must meet before being marketed.

Device	Model / Reference	Registries	Class	Status
Dentapen Protective Sleeve	Dentapen Protective Sleeve	FDA UDI	Class II	Active
Dentapen Protective Sleeve	Dentapen Protective Sleeve	FDA UDI	Class II	Active
Complete Dentapen Kit	Dentapen kit 01	FDA UDI	Class II	Active
Dentapen Battery	Dentapen for Dentapen	FDA UDI	Class II	Active
Dentapen Injector	Dentapen	FDA UDI	Class II	Active
Juvapen Expert syringe holder	JPE02	EUDAMED	Class I	Active
DENTAPEN Cartridge holder imperial	DP05	EUDAMEDFDA UDI	Class I	Active
DENTAPEN Pro imperial kit	DKPI	EUDAMED	Class IIa	Active
DENTAPEN Pro 2.2ml kit	DKP22ML	EUDAMED	Class IIa	Active
DENTAPEN Cartridge holder metric	DP03	EUDAMED	Class I	Active
Juvapen Expert	JPE01	EUDAMED	Class IIa	Active
DENTAPEN Cartridge holder 2.2ml	DP07	EUDAMED	Class I	Active
Dentapen finger grips	DP02	EUDAMEDFDA UDI	Class I	Active
IOL-Robotics adapter	IR02	EUDAMED	Class I	Active
Juvapen Toxin	JP01	EUDAMED	Class IIa	Active
DENTAPEN Pro metric kit	DKPM	EUDAMED	Class IIa	Active
IOL-Robotics	IR01	EUDAMED	Class IIa	Active
DENTAPEN Finger grips spix	DP04	EUDAMEDFDA UDI	Class I	Active
JUVAPEN Toxin syringe holder	JP02	EUDAMED	Class I	Active

JUVAPLUS SA

What JUVAPLUS SA makes

Frequently asked questions

Information

Catalogue (19)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities