Cardivais S.A.
Active in EUDAMEDSpainfrom SRN EUDAMED SRN ES-MF-000017980
- Devices
- 132
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
Catalogue
HKL, Biel Pack Ref 418088/03
Pack Ponction Ref 422079/01
Intensifier cover 95x115cm Ref 16130520
Angio-Pack Kantonsspital Olten Ref 420049/02
Cardiac surgery pack Ref 417103/03
Heart surgery drape 300/200x360cm Ref 16143400
Angio-pack VASC Gefässzentrum, Bern Ref 415038/01
Diathermy pouch 35x40cm Ref 16131208
Reinforced Surgical Gown SMMMS size "XL" Ref 12012240
Pack pour pose de stimulateur/défibrillateur HUG Ref 417108/04
Schaffhausen HKL-Pack Ref 422047/04
Pack radiologie interventionelle Ref 425010/01
CRT Pack KSSG Ref 426012/01
Desinfection Pack Ref 417001/01
Pacemaker drape 240x350cm Ref 16143202
Fenestrated surgical drape (IS) 150x120cm Ref 16109206
Fenestrated surgical drape (IS) 50x60cm Ref 16107302
Punktions-Pack, Radiologie KS (Luzern) Ref 412026/01
Kleineingriffe Pack, Neuroradiologie Insel (Bern) Ref 412082/03
Tumeszenz universal set Ref 418033/03
Radiologie-Pack Spital Thun Ref 424075/01
Pack Schale & Spritze rot Ref 423167/01
PICC Pack Spital Thun Ref 423162/02
Vascular surgery pack (A). CHUV (Lausanne) Ref 411002/09
Venefit Pack Ref 423043/03
Fenestrated surgical drape (IS) 100x135cm Ref 16109541
Laser set angiologie HUG Ref 415102/03
PICC-Pack Ref 423133/02
Circular intensifier cover 150x75cm Ref 16130533
Laser Set Ref 416009/05
Pack chirurgie vasculaire Ref 421076/03
Kleineingriffe Set Radiologie, Inselspital Ref 412086/03
Phleboset pack Ref 418020/03
Drainage Pack Beau-Site Ref 411007/02
Mini-Pack, Radiologie Ref 420041/02
Vitrectomy Pack Antonius Ziekenhuis Sneek Ref 426044/01
Venen-Pack Ref 423022/03
PICC-Pack, HUG Ref 424134/02
Ponction RX Pack Ref 414040/05
Endovenous pack Ref 419019/02
Screen cover 110x90cm Ref 16132000
PICC-Pack Ref 423113/02
Femoral angiography sheet 230x350cm Ref 16140100
Radiologie-Pack Schiers (Schiers) Ref 411027/05
HKL-Pack, Liestal Ref 425050/01
Radioablation pack Ref 426019/01
Feinnadel-set Ref 424004/01
TAVI Tisch-pack Ref 415005/03
PM Pack Ref 425038/01
Schmerztherapie Pack Spital Schiers Ref 416003/02
Showing 1-50 of 132
Company details
- EUDAMED SRN
- ES-MF-000017980
- EU VAT number
- ESA29025988
- EUDAMED status
- Active
- EUDAMED registered name
- CARDIVAIS S.A.
- Registered address
- 64, C/Severo Ochoa, 29590, Málaga, Spain
- Website
- www.cardivais.com
- linkedin.com/company/cardivais
- [email protected]
- Phone
- +34 952334350
- PRRC contact
- Amparo Delgado Narbona
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 30 May 2028
Notified body 0318 1 certificate
- 2025 PR 0047 Issued
Quality assurance EU MDR
- Issued
- 3 Mar 2026
- Expires
- 20 Apr 2030
Notified body 1639 1 certificate
- ES23/00000553 Issued
Quality management system EU MDR
- Issued
- 30 May 2023
- Expires
- 30 May 2028
From the company website
Cardiva Integral Solutions is the first Spanish company to manufacture single-use surgical coverage.
What Cardivais S.A. makes
Cardivais S.A. manufactures medical packaging solutions, including laser-marked protective covers for medical devices and sterile packaging kits for peripherally inserted central catheters (PICC). Their product line also includes radiology protection packs and various sterile barrier systems for medical equipment, designed to maintain sterility and integrity during use.
The company’s devices are classified under EU regulations as Class I and Class IIa, with all products listed in the EU’s medical device registry, eudamed. Cardivais S.A. is based in Spain and adheres to EU medical device compliance requirements for distribution and registration.
Frequently asked questions
How many devices does CARDIVAIS S.A. have in the registry?
The registry currently lists 132 devices for CARDIVAIS S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list CARDIVAIS S.A.'s devices?
Among its 50 most recently registered devices, CARDIVAIS S.A. has devices listed in EUDAMED (50 devices).
What risk classes do CARDIVAIS S.A.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for CARDIVAIS S.A.'s devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for CARDIVAIS S.A.?
EUDAMED lists 2 certificates for CARDIVAIS S.A. (quality assurance; quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 2026-03-03.
What are the newest devices from CARDIVAIS S.A. in the registry?
The most recently registered devices listed for CARDIVAIS S.A. include HKL, Biel Pack, Pack Ponction, Intensifier cover 95x115cm and Angio-Pack Kantonsspital Olten.