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DR HELEWA Hygienic Bags and Accessories
EUDAMEDClass I (EU MDR)
Ref BPCOVSTD
by Didactic
Identity
- Device Name
- DR HELEWA Hygienic Bags and Accessories EUDAMED
- Model / Reference
- BPCOVSTD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661809033575 EUDAMED
- Basic UDI-DI
- 3661809HELE5 EUDAMED
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
DR HELEWA Hygienic Bags and Accessories by Didactic — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose suction system, pneumatic.
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- Furine — Furine ApS · Class I
- Non-sterile aspiration tubes - Flexivac bags — Produtos Médicos Hospitalares, SA · Class I
- 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 | 3661809HELE5 | Class I | Active |
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Manufacturer
- Manufacturer
- Didactic
- EUDAMED SRN
- FR-MF-000000176
Sources (1)
- EUDAMED b8916d80-fa8c-4656-a50d-b6ff27d66099 61 fields · synced Jun 18, 2026