N/An/A MR1903224S
Ref MR1903224S
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number00884908318NB 00884908169140 | Date11 Jun 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00884908169140 | Date26 Jun 2019 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Medcomp Access Sets EUDAMEDN/An/A GUDID
- Generic Name
- Vascular catheter introduction needle
- Device Name
- Medcomp/Jet Peelable Introducers/Access Sets
- Model / Ref / Catalog
- MR1903224S
- Primary DI / UDI-DI
- 00884908169140 EUDAMED00884908104219 GUDID
- Basic UDI-DI
- 00884908318NB
- FDA Product Code
- DYB
- EMDN Code
- C0501 Cardiovascular introducer sheaths, non-valved
- GMDN Term
- Vascular catheter introduction needle
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 870.1340
- EU market of registration
- Netherlands
- GUDID distribution status
- Not in Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | 00884908169140 | 00884908104219 |
| Device Class | Class IIa | Class II |
Other devices from Medical Components Inc
Properties
Other properties (18)
- 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
- Over-the-Counter: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No