Curette Rigid Straight 11mm
by Medgyn International, Inc United States EUDAMEDGUDID
Ref 022211 Product code HCYEMDN U089010
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-M803022211 | Date17 Oct 2023 | StatusActive |
| United States | GUDID listing GUDID | NumberM803022211 | Date7 Sep 2016 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- MedGyn Uterine Curette
- Generic Name
- Intrauterine cannula, single-use
- Device Name
- Curette Rigid Straight 11mm
- Model / Ref / Catalog
- 022211, 11mm rigid straight curette
- Primary DI / UDI-DI
- M803022211
- Basic UDI-DI
- B-M803022211
- FDA Product Code
- HCY
- EMDN Code
- U089010 Uterine curettes, single-use
- GMDN Term
- Intrauterine cannula, single-use
- Device Class
- Class I
- Regulation Number
- 884.4530
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Safe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 022211 | 11mm rigid straight curette |
Manufacturer details
- EUDAMED SRN
- US-MF-000031450
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Medgyn International, Inc
Properties & raw data
Show properties, registry sources and raw records
Other properties (16)
- 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
Sources (2)
- EUDAMED 4025b6c4-cde8-49b2-9924-d0950f932a25
- FDA UDI b2fc2adb-7b70-4bdc-bb45-1e2eccab3c14