Identity
- Trade Name
- DUO Canister Set 1100 cc EUDAMED
- Device Name
- DUO Canister 1100 cc EUDAMED
- Model / Reference
- A7-S00D11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849405002215 EUDAMED
- Basic UDI-DI
- B-00849405002215 EUDAMED
- EMDN Code
- A060301 COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
DUO Canister Set 1100 cc by Genadyne Biotechnologies Inc. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00849405002215 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genadyne Biotechnologies, Inc.
- EUDAMED SRN
- US-MF-000017992
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 4e3328b0-4aaa-43a5-a938-1f3b45590ff1 61 fields · synced Jul 23, 2026