Enovate Medical FIPS Cryptographic Module for EcoFlex, Rhythm, Envoy, and Encore

Certificate

Module description

The Enovate Medical FIPS Cryptographic Module, based off of OpenSSL, is a general-purpose cryptographic module integrated in Enovate Medical's products such as EcoFlex, Rhythm, Envoy, and Encore to provide FIPS 140-2 validated cryptography for the protection of sensitive information.

Security level exceptions

• Roles, Services, and Authentication: Level 2
• Physical Security: N/A
• Design Assurance: Level 3
• Mitigation of Other Attacks: N/A

Approved algorithms

Allowed algorithms

Diffie-Hellman (key agreement; key establishment methodology provides between 112 and 256 bits of encryption strength); EC Diffie-Hellman (CVL Cert. #C1795, key agreement; key establishment methodology provides between 112 and 256 bits of encryption strength); NDRNG; RSA (key agreement; key establishment methodology provides between 112 and 256 bits of encryption strength)

Tested configurations

• Fedora Linux 24 running on Samsung ARTIK 710 SOM with ARM Cortex-A53 with PAA
• Fedora Linux 24 running on Samsung ARTIK 710 SOM with ARM Cortex-A53 without PAA
• Windows Server 2019 running on HPE ProLiant DL60 Gen9 with Intel Xeon E5-2609 with PAA
• Windows Server 2019 running on HPE ProLiant DL60 Gen9 with Intel Xeon E5-2609 without PAA (single user mode)

Validation history

Status timeline

As observed by this tracker's snapshots. NIST publishes no dates for list moves; observation began 2026-08-21, so earlier changes carry no date.

• 2026-08-21: first observed by this tracker, status historical
• Validation dates on record: 2020-09-08

Source documents

• NIST certificate page
• Security policy (PDF)
• Consolidated certificate (PDF)