MedGyn Pipette
by Medgyn International, Inc United States EUDAMEDGUDID
Ref 022721 Product code HHIEMDN U089010
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-m803022721 | Date1 Oct 2024 | StatusActive |
| United States | GUDID listing GUDID | Numberm803022721 | Date14 Dec 2020 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Generic Name
- Endometrial cytology brush
- Model / Ref / Catalog
- 022721, MedGyn Pipette 3.1mm O.D.
- Primary DI / UDI-DI
- m803022721
- Basic UDI-DI
- B-m803022721
- FDA Product Code
- HHI
- EMDN Code
- U089010 Uterine curettes, single-use
- GMDN Term
- Endometrial cytology brush
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 884.5070
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Safe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 022721 | MedGyn Pipette 3.1mm O.D. |
| Device Class | Class I | Class II |
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 29dcde3c-bcdb-430d-9396-b049d84d611a
- FDA UDI 429f17c0-10a1-4735-bb0d-e0a78d2cbce7