ANTEIS SA

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3007744205	3007744205	ANTEIS SA	1	N	2026-01-01	Chemin des aulx 12 Plan les ouates Geneve CH 1228

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
07640123791121	Belotero Balance - Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.	888-972-4588	myMerzSolutions@merz.com

merz.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
103943	1547122652	P250020	Belotero Volume (+) Lidocaine	LMH	2026-05-19
103943	1764682189	P090016	BELOTERO BALANCE	LMH	2011-11-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LMH	1	2011-11-14

GUDID#

Belotero Balance - Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.

ANTEIS SA

2020-10-01

Belotero Balance - Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.

ANTEIS SA

2019-02-01

Belotero Balance Lidocaine - Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction and treatment of moderate-to-severe facial wrinkles and folds, such as nasolabial folds, and for volume augmentation for the improvement of the infraorbital hollow in adults over the age of 21. The device is kitted in a blister pack containing: (1) a 1mL pre-filled syringe of sterile gel, and (2) two sterile needles (27G x 1/2, 30G x 1/2).

ANTEIS SA

2025-09-30

Belotero Balance Lidocaine - Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction and treatment of moderate-to-severe facial wrinkles and folds, such as nasolabial folds, and for volume augmentation for the improvement of the infraorbital hollow in adults over the age of 21. The device is kitted in a blister pack containing: (1) a 1mL pre-filled syringe of sterile gel, and (2) two sterile needles (27G x 1/2, 30G x 1/2).

ANTEIS SA

2025-09-30

Belotero Balance (+) Lidocaine - Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds and for volume augmentation for the improvement of the infraorbital hollow in adults over the age of 21. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance (+) Lidocaine gel in a 1 mL syringe, and (2) two sterile needles (27G x 1/2, 30G x 1/2).

ANTEIS SA

2023-06-01

Belotero Balance - Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.

ANTEIS SA

2023-06-01

Belotero Balance (+) Lidocaine - Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction and treatment of moderate-to-severe facial wrinkles and folds, such as nasolabial folds, and for volume augmentation for the improvement of the infraorbital hollow in adults over the age of 21. The device is kitted in a blister pack containing: (1) a 1mL pre-filled syringe of sterile gel, and (2) two sterile needles (27G x 1/2, 30G x 1/2).

ANTEIS SA

2023-06-01

Belotero Balance (+) Lidocaine - Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction and treatment of moderate-to-severe facial wrinkles and folds, such as nasolabial folds, and for volume augmentation for the improvement of the infraorbital hollow in adults over the age of 21. The device is kitted in a blister pack containing: (1) a 1mL pre-filled syringe of sterile gel, and (2) two sterile needles (27G x 1/2, 30G x 1/2).

ANTEIS SA

2021-01-01

Belotero Balance (+) Lidocaine - Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction and treatment of moderate-to-severe facial wrinkles and folds, such as nasolabial folds, and for volume augmentation for the improvement of the infraorbital hollow in adults over the age of 21. The device is kitted in a blister pack containing: (1) a 1mL pre-filled syringe of sterile gel, and (2) two sterile needles (27G x 1/2, 30G x 1/2).

ANTEIS SA

2021-01-01