Olympus WA64700L
Ref WA64700L
Active
CE MDD
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-04042761068871 04042761068871 | Date5 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04042761068871 | Date21 Sep 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 24 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Jaws "HiQ+", 5 x 430 mm, needle holder, straight EUDAMEDOlympus GUDID
- Generic Name
- Suturing needle holder, reusable
- Model / Ref / Catalog
- WA64700L
- Primary DI / UDI-DI
- 04042761068871
- Basic UDI-DI
- B-04042761068871
- FDA Product Code
- GCJ, HET
- EMDN Code
- L1205 Laparoscopic and thoracoscopic surgery needle holders, reusable
- GMDN Term
- Suturing needle holder, reusable
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 876.1500, 884.1720
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Other devices from Olympus Winter & Ibe GmbH
Properties
Other properties (22)
- Sterile: No
- Single Use: No
- 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
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No