ab medica spa
Active in EUDAMEDItalyfrom SRN EUDAMED SRN IT-MF-000029717
Part of Medica Corp.
- Devices
- 28
- Registrations
- EUDAMED
- FDA recalls
- 51 ongoing
At a glance
EU certificates
3 of 3 in force.
Market reach
- European Union
- EUDAMED actor, 3 certificates
- United States
- FDA recalls
Catalogue
Search and filter all 28 devicesCompany details
- EUDAMED SRN
- IT-MF-000029717
- SRN (system / procedure pack)
- IT-PR-000029708
- EU VAT number
- 08862820969
- EUDAMED status
- Active
- EUDAMED registered name
- ab medica spa
- EUDAMED abbreviated name
- ab medica
- Registered address
- 1/a, Via Felice Casati, 20124, Milano, Italy
- Website
- www.abmedica.it
- facebook.com/abmedicaita
- [email protected]
- Phone
- +39 02 933051
- PRRC contact
- Cesare Giuseppe Pirola
EUDAMED certificates
3 certificates3 valid, 0 expiredMDR 3next expiry 30 Jul 2029
ICIM S.P.A. 0425 2 certificates
- 0425-MDR-030157-00 Issued
Quality management system EU MDR
- Issued
- 12 Nov 2025
- Expires
- 11 Nov 2030
- 0425-MDR-030088-00 Issued
Quality management system EU MDR
- Issued
- 31 Jul 2024
- Expires
- 30 Jul 2029
TUV Rheinland Italia SRL 1936 1 certificate
- ITH 1343151 1 Supplemented
Quality management system EU MDR
- Issued
- 7 Oct 2026
- Expires
- 27 Sep 2031
- Reason
- Other
FDA recalls
Recalls initiated per year
- 2017 2
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 31 Dec 2025 Z-1370-2026 Class II Ongoing A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
2019
- 6 Feb 2019 Z-1294-2019 Class II Terminated Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.
Full distribution text
- 6 Feb 2019 Z-1294-2019 Class II Terminated Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.
2017
- 21 Nov 2017 Z-1149-2018 Class II Terminated The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. The firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover from the triglyceride (TRIG) assay if they are on the same worklist.
- 11 Apr 2017 Z-1267-2018 Class II Terminated Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
2010
- 29 Mar 2010 Z-0078-2011 Unclassified (pre-2012) Terminated Chemistry analyzers may report Calcium results below the sample's actual concentration. Reported results may be ten to fifteen percent lower than expected sample results.
The defect is a shortened path length at specific cuvette positions of those segments manufactured using molding cavity 1. The shortened path length was determined by measuring the cuvette dimensions with a Co-ordinate Measuri
Full distribution text
- 29 Mar 2010 Z-0078-2011 Unclassified (pre-2012) Terminated Chemistry analyzers may report Calcium results below the sample's actual concentration. Reported results may be ten to fifteen percent lower than expected sample results.
The defect is a shortened path length at specific cuvette positions of those segments manufactured using molding cavity 1. The shortened path length was determined by measuring the cuvette dimensions with a Co-ordinate Measuri
From the company website
ab medica s.p.a. J.F. Kennedy 10/12 20023 Cerro Maggiore (MI) Tel +39 02.93305.1 Fax +39 02.93305.400 [email protected] register companies n° 08862820969 share capital paid € 10,000,000,000
Frequently asked questions
How many devices does ab medica spa have in the registry?
The registry currently lists 28 devices for ab medica spa. Devices recorded under merged duplicate company entries are counted once.
Which registries list ab medica spa's devices?
Among its 28 most recently registered devices, ab medica spa has devices listed in EUDAMED (28 devices).
What risk classes do ab medica spa's devices fall under?
Among its 28 most recently registered devices, the classes recorded for ab medica spa's devices are Class I and Class IIa. Each device page shows its own class and authorisation.
Are there FDA recall records for ab medica spa?
FDA recall records list 5 recalls initiated by ab medica spa, the most recent initiated on 2025-12-31. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for ab medica spa?
EUDAMED lists 3 certificates for ab medica spa (quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 2026-10-07.
What are the newest devices from ab medica spa in the registry?
The most recently registered devices listed for ab medica spa include Wellet, Dolphin, Carepad XL and Robotic Tray.