Reflex
by Conmed Corporation United States EUDAMEDGUDID
Ref 3036
Product code FZQEMDN H02010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-20653405048388 | Date9 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number20653405048388 | Date14 Oct 2021 | StatusListed |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Reflex EUDAMEDGUDIDConmed Reflex GUDID
- Generic Name
- Electrical-only medical device connection cable, reusableSkin stapler/staple, non-bioabsorbable
- Device Name
- Non-orthopedic, Non-active, Instrument, Stapler/Staple
- Model / Ref / Catalog
- 3036, 8935
- Primary DI / UDI-DI
- 20653405048388, 20653405047091
- Basic UDI-DI
- B-20653405048388
- FDA Product Code
- FZQ, QQS
- EMDN Code
- H02010102 Skin staplers, single patient
- GMDN Term
- Electrical-only medical device connection cable, reusableSkin stapler/staple, non-bioabsorbable
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 878.4320, 878.4740
- Market of Registration
- Belgium
- Commercial Distribution
- Not in Commercial DistributionIn Commercial Distribution
- Sterilization Method
- Ethylene Oxide
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000012663
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Conmed Corporation
Properties & raw data
Show properties, registry sources and raw records
Other properties (18)
- 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
- Serial Number: No
- Manufacturing Date: No
Sources (3)
- EUDAMED b3a9ea58-d205-409e-83ca-bf11f6d03035
- FDA UDI 121c3a5a-5212-4fb1-a785-155561b87311
- FDA UDI aaaf633e-08af-41d2-bcb9-2e1aae67c71c