Bambi Belt B.V.
Active in EUDAMEDNetherlandsfrom SRN EUDAMED SRN NL-MF-000010914
- Devices
- 6
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Bambi Belt B.V. makes
Bambi Belt B.V. manufactures general-purpose multi-parameter bedside monitors, specifically the Bambi Belt in various sizes (Size 1, Size 2, Size 3, and Size 4), along with the Bambi Interface.
The company's devices are classified as Class I and Class IIa and are listed in the eudamed registry. Bambi Belt B.V. is based in the Netherlands.
Catalogue
- Regimes: CE MDR Registry: EUDAMED
Bambi Belt Size 1 Ref BELT-N01.1
Regimes: CE MDR Registry: EUDAMEDBambi Belt Size 3 Ref BELT-N01.3
Regimes: CE MDR Registry: EUDAMEDBambi Belt Size 2 Ref BELT-N01.2
Regimes: CE MDR Registry: EUDAMEDBambi Interface Ref BI-N01
Regimes: CE MDR Registry: EUDAMEDBambi Belt Size 4 Ref BELT-N01.4
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- NL-MF-000010914
- EU VAT number
- NL858153099B01
- EUDAMED status
- Active
- EUDAMED registered name
- Bambi Belt B.V.
- EUDAMED abbreviated name
- Bambi Belt
- Registered address
- 29, High Tech Campus, 5656AE, Eindhoven, Netherlands
- Website
- www.bambi-medical.com
- facebook.com/BambiMedical
- [email protected]
- Phone
- +31402881177
- PRRC contact
- Fabio Bambang Oetomo
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 9 May 2028
DNV Product Assurance AS 2460 1 certificate
- 10000468205-PA-NoMA-CZE Active
Quality management system EU MDR
- Issued
- 9 May 2023
- Expires
- 9 May 2028
From the company website
Bambi Medical makes babies’ lives happier from day one by developing, testing and producing new technologies for the NICU, such as the Bambi Belt.
Frequently asked questions
How many devices does Bambi Belt B.V. have in the registry?
The registry currently lists 6 devices for Bambi Belt B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bambi Belt B.V.'s devices?
Among its 6 most recently registered devices, Bambi Belt B.V. has devices listed in EUDAMED (6 devices).
What risk classes do Bambi Belt B.V.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Bambi Belt B.V.'s devices are Class I, Class IIa and Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Bambi Belt B.V.?
EUDAMED lists 1 certificate for Bambi Belt B.V. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 9 May 2023.
What are the newest devices from Bambi Belt B.V. in the registry?
The most recently registered devices listed for Bambi Belt B.V. include EXG System, Bambi Belt Size 1, Bambi Belt Size 3 and Bambi Belt Size 2.