Meridian Classic Cranial Perforator
by adeor medical AG EUDAMEDGUDID
Active
Ref PER 11-14-S, PER C6-9-SModel Meridian Classic Perforator Ø11/14 mm, 2.0 mm, Meridian Classic Perforator Ø6/9 mm, 2.0 mm
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-04251388937570 | Date17 Apr 2025 | StatusActive |
| United States | GUDID listing GUDID | Number04251388937570 | Date11 Feb 2017 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- Meridian Classic Cranial Perforator EUDAMEDMeridian Perforator GUDID
- Generic Name
- Automatic cranial perforator, single-use
- Model / Ref / Catalog
- Meridian Classic Perforator Ø11/14 mm, 2.0 mm, PER 11-14-S, Meridian Classic Perforator Ø6/9 mm, PER C6-9-S, Classic
- Primary DI / UDI-DI
- 04251388937570 EUDAMED04251388938690 EUDAMEDEADEPERC69S1 GUDID
- Basic UDI-DI
- B-04251388937570, B-04251388938690
- 510(k) Number
- FDA Product Code
- HBF
- EMDN Code
- P091304 Cranial perforators, single-use
- GMDN Term
- Automatic cranial perforator, single-use
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 882.4305
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Meridian Classic Perforator Ø11/14 mm, 2.0 mm PER 11-14-S Meridian Classic Perforator Ø6/9 mm, 2.0 mm PER C6-9-S | Classic |
| Primary DI / UDI-DI | 04251388937570 04251388938690 | EADEPERC69S1 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- DE-MF-000011451
Other devices from adeor Medical AG
Properties
Show properties
Other properties (17)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No