SEAL™ Base
by Galaxy Therapeutics, Inc. 7 variants
Ref FG0006-03E
Active
CE MDR
Valid until
28 Jul 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000269457 | Date29 Jul 2026 | StatusActive |
Certificates
- 1000269457 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 29 Jul 2026
- Expires
- 28 Jul 2031
- 1000322051 Active
Technical documentation EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 29 Jul 2026
- Expires
- 28 Jul 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SEAL™ Embolization System
- Model / Reference
- FG0006-03E
- Primary DI / UDI-DI
- 00850052512187
- Basic UDI-DI
- 0850052512SEALSV
- EMDN Code
- C01050299 Intravascular embolic protection catheters and systems - other
- Device Class
- Class III
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- US-MF-000035675
- Authorised representative
- Specculo Limited MT-AR-000034988
Other devices from Galaxy Therapeutics, Inc.
Properties
Other properties (11)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No