Identity
- Trade Name
- UNO+ 100 CC EUDAMED
- Device Name
- UNO Plus 100 CC Collection Canister EUDAMED
- Model / Reference
- UP-S00D1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849405002321 EUDAMED
- Basic UDI-DI
- B-00849405002321 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
- Spain 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
Category: Negative-pressure wound therapy system canister
Uno+ 100 Cc by Genadyne Biotechnologies Inc. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system canister.
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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-00849405002321 | Class I | Active |
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Manufacturer
- Manufacturer
- Genadyne Biotechnologies, Inc.
- EUDAMED SRN
- US-MF-000017992
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 684f20ab-7bb6-4900-912f-dae34a18e5b0 61 fields · synced Jul 12, 2026