Enzymatica AB
Active in EUDAMEDSwedenfrom SRN EUDAMED SRN SE-MF-000002254
- Devices
- 13
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
What Enzymatica AB makes
Enzymatica AB produces enzyme-based products designed to support the body’s natural defense mechanisms against viruses, irritants, and microorganisms. The portfolio includes topical enzyme formulations like ColdZyme (in variants such as Eucalyptus and Strawberry) and ViruProtect, which are intended for skin application to aid in immune response. ColdGuard is also part of the lineup, likely serving a similar purpose in a different formulation or application.
All listed devices fall under EU Medical Device Regulation (MDR) Class III, requiring stringent conformity assessments. The products are registered in the EU’s eudamed database, ensuring traceability and compliance with EU medical device legislation. The company is headquartered in Sweden.
Catalogue
Search and filter all 13 devicesCompany details
- EUDAMED SRN
- SE-MF-000002254
- EU VAT number
- SE556719924401
- EUDAMED status
- Active
- EUDAMED registered name
- Enzymatica AB
- Registered address
- Ideon Science Park, 22370, Lund, Sweden
- Website
- www.enzymatica.com
- linkedin.com/company/enzymatica
- [email protected]
- Phone
- +46 46 286 31 00
- PRRC contact
- Ann-Christine Provoost
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 6 Mar 2029
Notified body 0477 2 certificates
- EPT 0477.MDR.24/5405 Active
Technical documentation EU MDR
- Issued
- 7 Mar 2024
- Expires
- 6 Mar 2029
- EPT 0477.MDR.24/5406 Active
Quality management system EU MDR
- Issued
- 7 Mar 2024
- Expires
- 6 Mar 2029
From the company website
Enzymatica develops solutions that support the body's own defenses against virus, irritants and microorganisms.
Frequently asked questions
How many devices does Enzymatica AB have in the registry?
The registry currently lists 13 devices for Enzymatica AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Enzymatica AB's devices?
Among its 13 most recently registered devices, Enzymatica AB has devices listed in EUDAMED (13 devices).
What risk classes do Enzymatica AB's devices fall under?
Among its 13 most recently registered devices, the classes recorded for Enzymatica AB's devices are Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Enzymatica AB?
EUDAMED lists 2 certificates for Enzymatica AB (technical documentation; quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 2024-03-07.
What are the newest devices from Enzymatica AB in the registry?
The most recently registered devices listed for Enzymatica AB include Virustad Erkältungsspray 7 ml, Virustad Erkältungsspray, Virustad Erkältungsspray Erdbeere and ColdZyme 20 ml.