Miaspas
by Aesculap AG EUDAMEDGUDID
Active
Ref EJ361R
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number40392390000016562X | Date13 Oct 2025 | StatusActive |
| United States | GUDID listing GUDID | Number04038653267453 | Date21 Jun 2019 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Generic Name
- Laparoscopic dilation guide rod
- Device Name
- MIASPAS instrument Ir
- Model / Ref / Catalog
- EJ361R
- Primary DI / UDI-DI
- 04038653267453
- Basic UDI-DI
- 40392390000016562X
- Direct Marketing DI
- 04038653267453
- FDA Product Code
- GCJ
- EMDN Code
- L091199 Orthopaedic prosthetics instruments, reusable - other
- GMDN Term
- Laparoscopic dilation guide rod
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 876.1500
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- DE-MF-000005504
Other devices from Aesculap AG
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: 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
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No