grism Stent Retriever
by AccuMedical Inc. 6 variants
Ref CR0404EP
Active
CE MDR
Valid until
18 Jun 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697397126CRDLEPU7 06973971269148 | Date10 Aug 2026 | StatusActive |
Certificates
- MDR.2292-2026/0036 Active
Technical documentation EU MDR
- Certifier
- UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
- Issued
- 19 Jun 2026
- Expires
- 18 Jun 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- CR0404EP
- Primary DI / UDI-DI
- 06973971269148
- Basic UDI-DI
- 697397126CRDLEPU7
- EMDN Code
- C010401020501 Manual cardiac thrombectomy and thromboaspiration systems
- Device Class
- Class III
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000048745
- Authorised representative
- Debao International GmbH DE-AR-000046097
Other devices from AccuMedical Inc.
Properties
Other properties (12)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No