FEM

FDA UDI

Gc Orthodontics America Inc.·D78840247001681·FEM LP SINGL LR7 -10T 0Ax.022 911-06515

FEM

FDA UDI

Gc Orthodontics America Inc.·D78840237001681·FEM LP SINGLE LL7 -10T 0Ax.022 911-06514

FEM

FDA UDI

Gc Orthodontics America Inc.·D78840236001681·FEM LP SINGL LL6 -20T 0Ax.022 911-06512

Erbozeta S.p.A.

Manufacturer

🇸🇲 San Marino

LSM-MED S.r.l.

Manufacturer

🇸🇲 San Marino·1 Basic UDI-DI·3 Devices·2 Importers·ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

PromoPharma spa

Manufacturer

🇸🇲 San Marino

TISS'YOU S.R.L.

Manufacturer

🇸🇲 San Marino·14 Basic UDI-DIs·14 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Pharmaluce s.r.l.

Manufacturer

🇸🇲 San Marino

Logus Pharma s.r.l.

Manufacturer

🇸🇲 San Marino

Cytodiagnostic srl

Manufacturer

🇸🇲 San Marino·1 Basic UDI-DI·4 Devices

Carbon Fiber Table CFT Series; CFT-C8; CFT-C8-01; CFT-L7; CFT-L6; CFT-K6; CFT-i6.

FDA registration

Shanghai PAX Medical Instrument Co., Ltd.·1 product·🇨🇳 China

WALKER, ROLLATOR

FDA registration

JINHUA QUAL-MAX TRADING CO., LTD·1 product·🇨🇳 China

Electric Examination Table DJ Series: DJ100; DJ180; DJ200.

FDA registration

Shanghai PAX Medical Instrument Co., Ltd.·1 product·🇨🇳 China

Examination Light: a) ELD Series; ELD ; ELD10; ELD20; b) DK/L.

FDA registration

Shanghai PAX Medical Instrument Co., Ltd.·1 product·🇨🇳 China

Orthopedic Extension Device: 1008; 1009

FDA registration

Shanghai PAX Medical Instrument Co., Ltd.·1 product·🇨🇳 China

Mechanical Operating Table ST Series: ST-A; ST-B; ST-C; ST-D.

FDA registration

Shanghai PAX Medical Instrument Co., Ltd.·1 product·🇨🇳 China

Minor LED Surgical Light: a) PML30 Series: PML30(Ceiling); PML30(Wall-mount); PML30(Mobile); PML30(Ceiling);

FDA registration

Shanghai PAX Medical Instrument Co., Ltd.·1 product·🇨🇳 China

Operating Light: PANALEX 3; PANALEX 4.

FDA registration

Shanghai PAX Medical Instrument Co., Ltd.·1 product·🇨🇳 China

Massage Gun

FDA registration

JINHUA QUAL-MAX TRADING CO., LTD·1 product·🇨🇳 China

TOTIM Patient Cushion Immobilization System

FDA 510(k)

FDA Class 2 ·Radiology