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hygh-tec bag
EUDAMEDClass I (EU MDR)
Ref V01-10016-10Model stool collection bagRef V01-10016-05
Identity
- Trade Name
- hygh-tec bag EUDAMED
- Model / Reference
- stool collection bag EUDAMEDV01-10016-10 EUDAMEDV01-10016-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260566430031 EUDAMED04260566430024 EUDAMED
- Basic UDI-DI
- 426056643hyghtecaccN5 EUDAMED
- Direct Marketing DI
- 04260566430031 EUDAMED04260566430024 EUDAMED
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I 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 bag by Advanced Medical Balloons Gmbh — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 426056643hyghtecaccN5 | Class I | Active |
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Manufacturer
- Manufacturer
- Advanced Medical Balloons GmbH
- EUDAMED SRN
- DE-MF-000008364
Sources (2)
- EUDAMED d1f0fc8e-186d-4620-b2dc-9dfe69c02a3b 61 fields · synced Jul 9, 2026
- EUDAMED 6d770b3a-96f9-4ac8-9567-8c1a4d7b2649 61 fields · synced May 17, 2026