Huma
by Huma Therapeutics Limited 2 variants
Ref HUMA THERAPEUTICSModel V1.39
Active
CE MDR
Valid until
1 Mar 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++G287HUMAII7R ++G287HUMA138YU | Date28 Aug 2026 | StatusActive |
Certificates
- 1000316138 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 9 Jul 2026
- Expires
- 1 Mar 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Huma
- Model / Reference
- V1.39, HUMA THERAPEUTICS
- Primary DI / UDI-DI
- ++G287HUMA138YU
- Basic UDI-DI
- ++G287HUMAII7R
- EMDN Code
- V92 Medical device software - not included in other classes
- Device Class
- Class IIb
- Special Device Type
- Software
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- GB-MF-000031420
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Huma Therapeutics Limited
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No