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hygh-tec basic-plus
EUDAMEDClass IIa (EU MDR)
Ref V01-10023Model stool drainage system
Identity
- Trade Name
- hygh-tec basic-plus EUDAMEDhygh-tec basic plus EUDAMED
- Device Name
- stool drainage system EUDAMED
- Model / Reference
- stool drainage system EUDAMEDV01-10023 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260566430109 EUDAMED
- Basic UDI-DI
- B-04260566430109 EUDAMED426056643A060399H5 EUDAMED
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
hygh-tec basic-plus by Advanced Medical Balloons Gmbh — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose suction system, pneumatic.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04260566430109 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04260566430109 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Advanced Medical Balloons GmbH
- EUDAMED SRN
- DE-MF-000008364
Sources (2)
- EUDAMED 3454f926-a9ad-4a53-b4a3-f604d86f163d 61 fields · synced Jun 19, 2026
- EUDAMED af6edd95-d0e0-4f87-b288-bc075edaf08b 61 fields · synced May 19, 2026