ALFAMEDIC s.r.o.

Czechia CZ-MF-000037764 Last updated 8 Jun 2026

Is this your brand? Sign in to claim this brand

Devices: 16
Registries: EUDAMED
FDA recalls: 0

Catalogue16

Heated bed for newborns and infants VL-22 Ref VL-22-G-O

Class IIb EUDAMED Active
Heated bed for newborns and infants VL-22 Ref VL-22F-G-Z

Class IIb EUDAMED Active
Newborn bed MINI Ref MINI 2

Class I EUDAMED Active
Heated pad HM-13 Ref HM-13 S

Class IIa EUDAMED Active
Heated pad HM-13 Ref HM-13 M

Class IIa EUDAMED Active
Heated bed for newborns and infants VL-22 Ref VL-22F-S-Z

Class IIb EUDAMED Active
Heated bed for newborns and infants VL-22 Ref VL-22-S-Z

Class IIb EUDAMED Active
Heated bed for newborns and infants VL-22 Ref VL-22-S-B

Class IIb EUDAMED Active
Heated pad HM-13 Ref HM-13 V

Class IIa EUDAMED Active
Heated bed for newborns and infants VL-22 Ref VL-22-S-M

Class IIb EUDAMED Active
Heated bed for newborns and infants VL-22 Ref VL-22-G-M

Class IIb EUDAMED Active
Newborn bed ALFANEST Ref ALFANEST 2

Class I EUDAMED Active
Newborn bed ALFANEST Ref ALFANEST

Class I EUDAMED Active
Phototherapy lamp FL-2010 Ref FL-2010

Class IIa EUDAMED Active
Heated bed for newborns and infants VL-22 Ref VL-22F-S-M

Class IIb EUDAMED Active
Heated bed for newborns and infants VL-22 Ref VL-22F-S-B

Class IIb EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

3EC International a.s. 2265 1 certificate

2025-MDR/QS-031 Issued

Quality management system EU MDR

Issued
3 Jun 2025

Expires
3 Jun 2030

Notified bodies

3EC International a.s. 2265

About

Rely onOur products are characterized by superior quality, superior safety and long service life.Unique technologyUniqueness, safety, precision, durability.WorldwidePerfection for the Czech and…

From the manufacturer's own website. Source

What ALFAMEDIC s.r.o. makes

Alfamedic produces newborn care devices, including heated beds for infants and phototherapy lamps designed for neonatal treatment. Their product line includes the ALFANEST newborn bed and the VL-22 heated bed, which are intended for use in neonatal units. The FL-2010 phototherapy lamp is used for treating jaundice in newborns.

The company’s devices are classified under EU medical device regulations as Class I, Class IIa, and Class IIb. These products are listed in the EU’s eudamed registry, and the manufacturer is based in the Czech Republic.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Czechia
Address: 458/35, Tř. 5. května, Lišov (okres České Budějovice), Czechia
Website: www.alfamedic.cz
Email: [email protected]
Phone: +420602409301
PRRC contact: Vladimír Čapek
EUDAMED SRN: CZ-MF-000037764

Catalogue16

Heated bed for newborns and infants VL-22 Ref VL-22-G-O

Heated bed for newborns and infants VL-22 Ref VL-22F-G-Z

Newborn bed MINI Ref MINI 2

Heated pad HM-13 Ref HM-13 S

Heated pad HM-13 Ref HM-13 M

Heated bed for newborns and infants VL-22 Ref VL-22F-S-Z

Heated bed for newborns and infants VL-22 Ref VL-22-S-Z

Heated bed for newborns and infants VL-22 Ref VL-22-S-B

Heated pad HM-13 Ref HM-13 V

Heated bed for newborns and infants VL-22 Ref VL-22-S-M

Heated bed for newborns and infants VL-22 Ref VL-22-G-M

Newborn bed ALFANEST Ref ALFANEST 2

Newborn bed ALFANEST Ref ALFANEST

Phototherapy lamp FL-2010 Ref FL-2010

Heated bed for newborns and infants VL-22 Ref VL-22F-S-M

Heated bed for newborns and infants VL-22 Ref VL-22F-S-B