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Uniloo
EUDAMEDClass I (EU MDR)
Ref 10010Model Hygiejnisk hjælpemiddel
by Goloo A/S
Identity
- Trade Name
- Uniloo EUDAMED
- Device Name
- Softloo EUDAMED
- Model / Reference
- Hygiejnisk hjælpemiddel EUDAMED10010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05711024100106 EUDAMED
- Basic UDI-DI
- 5711024HYGIEJNEHJUR EUDAMED
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose suction system, pneumatic
Uniloo by Goloo A/S — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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- VarioAir B BS — Drägerwerk AG & Co. KGaA · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5711024HYGIEJNEHJUR | Class I | Active |
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Manufacturer
- Manufacturer
- Goloo A/S
- EUDAMED SRN
- DK-MF-000040727
Sources (1)
- EUDAMED b934d6ca-73b7-4ba7-a418-cb70b8c43cf8 61 fields · synced Aug 4, 2026