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DR HELEWA Hygienic Bags and Accessories
EUDAMEDClass I (EU MDR)
Ref W60012ICRef U60020Ref U60012ICRef VOMHOLDERRef C60020Ref C60012ICRef URIHOLDERRef B60012ICRef W60020
by Didactic
Identity
- Device Name
- DR HELEWA Hygienic Bags and Accessories EUDAMED
- Model / Reference
- W60012IC EUDAMEDU60020 EUDAMEDU60012IC EUDAMEDVOMHOLDER EUDAMEDC60020 EUDAMEDC60012IC EUDAMEDURIHOLDER EUDAMEDB60012IC EUDAMEDW60020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661809034206 EUDAMED03661809030345 EUDAMED03661809034299 EUDAMED03661809033483 EUDAMED03661809030017 EUDAMED03661809034268 EUDAMED03661809033452 EUDAMED03661809034237 EUDAMED03661809030406 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
Similar devices
Also classified as General-purpose suction system, pneumatic.
- Furine Collect — Furine ApS · Class I
- VarioAir D DIN — Drägerwerk AG & Co. KGaA · Class IIa
- Furine plus — Furine ApS · Class I
- VarioAir B/OP Schiene Diss — Drägerwerk AG & Co. KGaA · Class IIa
- Non-sterile aspiration tubes - Flexivac bags — Produtos Médicos Hospitalares, SA · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Didactic
- EUDAMED SRN
- FR-MF-000000176
Sources (9)
- EUDAMED 180f7e53-d8fb-459a-9c0d-7a4091ebdda3 61 fields · synced Sep 18, 2026
- EUDAMED 0c7ceb8e-6ca2-4ba4-87c5-b5190aca5da6 61 fields · synced May 17, 2026
- EUDAMED a2262b6a-ad02-4626-88ea-8284f795758e 61 fields · synced May 17, 2026
- EUDAMED b04780af-8587-4be2-9c48-67e3be6ae57e 61 fields · synced May 17, 2026
- EUDAMED 688e0b51-73fd-4e77-b54b-46c63aa74afd 61 fields · synced May 17, 2026
- EUDAMED 2dc07906-2505-4d08-8e44-5ab7fe86ab17 61 fields · synced May 17, 2026
- EUDAMED 36a71dd2-6bdc-4d74-a333-4c549a8d6956 61 fields · synced May 18, 2026
- EUDAMED 19f850c1-15e3-46c1-b2b3-6de02de90ecc 61 fields · synced May 18, 2026
- EUDAMED 1297d5aa-854f-4d8c-9a20-83ac07ce9098 61 fields · synced May 19, 2026