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WUNDER SA.BI. S.R.L.

Italy IT-MF-000028482 Last updated 17 Sep 2026

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Devices
71
Registries
EUDAMED
FDA recalls
0

Catalogue71

Page 1 of 2

  • Rw 2.0 Move Ref 00092S

    Class I EUDAMED Active
  • Pl-Vega Ref EBT519WA

    Class I EUDAMED Active
  • Pl-Vega Ref EBT514WA

    Class I EUDAMED Active
  • Ps-20 Ref 00090GB

    Class I EUDAMED Active
  • BABY02 con WH80D Ref 000482H+00060HM

    Class I EUDAMED Active
  • RA con WH200 Ref 00071A+00069AB

    Class I EUDAMED Active
  • BABY02 con WH80 Ref 000482G+00060M

    Class I EUDAMED Active
  • 960A Ref 00011A

    Class I EUDAMED Active
  • RA con WH200 Ref 00071B+00069AB

    Class I EUDAMED Active
  • Rb-L Ref 00071M

    Class I EUDAMED Active
  • RA con WH200D Ref 00071B+00051D

    Class I EUDAMED Active
  • Pl-AP4300 Ref AP4300WA

    Class I EUDAMED Active
  • C201 Ref 8

    Class I EUDAMED Active
  • Superbaby Ref 290

    Class I EUDAMED Active
  • R2020 con WH200 Ref 00073+00069AB

    Class I EUDAMED Active
  • Rh Ref 00071C

    Class I EUDAMED Active
  • Rw-Xl Ref 00092TB

    Class I EUDAMED Active
  • RB con WH200 Ref 00071I+00069AB

    Class I EUDAMED Active
  • Rw 2.0 Basic Ref 00092RA

    Class I EUDAMED Active
  • BABY02 con WH80 Ref 000482E+00060M

    Class I EUDAMED Active
  • Rw 2.0 Basic Ref 00092SA

    Class I EUDAMED Active
  • BABY02 con WH80D Ref 000482D+00060HM

    Class I EUDAMED Active
  • DE20 Ref 00091DA

    Class I EUDAMED Active
  • RH con WH200D Ref 00071C+00051D

    Class I EUDAMED Active
  • DE5 Ref 00091B

    Class I EUDAMED Active
  • BABY02 Ref 000482F

    Class I EUDAMED Active
  • RS180 Ref 00090EH

    Class I EUDAMED Active
  • Ps-20 Ref 00090GA

    Class I EUDAMED Active
  • Rw 2.0 S Ref 00092RB

    Class I EUDAMED Active
  • Pl-Vega Ref EBT510WA

    Class I EUDAMED Active
  • Pl-Vega Ref EBT519W

    Class I EUDAMED Active
  • Pl-Vega Ref EBT511W

    Class I EUDAMED Active
  • RW3.0 Ref 00092L

    Class I EUDAMED Active
  • Ra Ref 00071B

    Class I EUDAMED Active
  • Pl-Vega Ref EBT511WA

    Class I EUDAMED Active
  • RW3.0 Ref 00092LA

    Class I EUDAMED Active
  • RB con WH200D Ref 00071I+00051D

    Class I EUDAMED Active
  • DE5 Ref 00091BA

    Class I EUDAMED Active
  • Ra Ref 00071A

    Class I EUDAMED Active
  • BABY02 con WH80D Ref 000482I+00060HM

    Class I EUDAMED Active
  • R150A con WH200 Ref 00021A+00069AB

    Class I EUDAMED Active
  • BABY02 con WH80D Ref 000482F+00060HM

    Class I EUDAMED Active
  • Rl Ref 94

    Class I EUDAMED Active
  • RS300 Ref 00090EB

    Class I EUDAMED Active
  • Pl-Vega Ref EBT514W

    Class I EUDAMED Active
  • DE20 Ref 00091DB

    Class I EUDAMED Active
  • RW02 Ref 00092G

    Class I EUDAMED Active
  • Pl-AP4300 Ref AP4300W

    Class I EUDAMED Active
  • RH con WH200 Ref 00071C+00069AB

    Class I EUDAMED Active
  • Rw 2.0 S Ref 00092SB

    Class I EUDAMED Active

Showing 1-50 of 71

EUDAMED certificates1

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

EUDAMED certificates (1)

ICIM S.P.A. 0425 1 certificate

  • 0425-MDR-030050-01 Issued

    Quality assurance EU MDR

    Issued
    29 Oct 2024
    Expires
    22 Oct 2028

Notified bodies

About

For more than fifty years Wunder is inspired by what is not only an idea, but a philosophy that guides our work: precision.

Translated from the manufacturer's own website. Source

What WUNDER SA.BI. S.R.L. makes

Wunder SA.BI. S.R.L. manufactures a range of Class I medical devices primarily focused on respiratory and neonatal care, including ventilators (e.g., RW 2.0 MOVE, PL-VEGA, PS-20), neonatal ventilators (e.g., BABY02 con WH80, SUPERBABY), and respiratory support systems (e.g., RA con WH200D, R2020 con WH200). Additional products include portable respiratory devices (e.g., PL-AP4300) and monitoring or accessory units (e.g., C201, RH, RB con WH200).

The company’s devices are classified under EU Class I and are listed in the EUDAMED registry. Wunder SA.BI. S.R.L. is based in Italy and adheres to EU medical device regulations, ensuring compliance with mandatory requirements for Class I products.

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

Information

Country
Italy
Address
7, VIA MONTE GRAPPA, BERGAMO, Italy
Website
www.wunder.it
Phone
+39 02 90964566
PRRC contact
Riccardo Bassi
EUDAMED SRN
IT-MF-000028482