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Passive Drainage with Soft Silicone Drain 18Fr, 100cm, 500ml Collecting Bag
EUDAMEDClass IIa (EU MDR)
Ref FR-76184Model FR-76081
Identity
- Trade Name
- Passive Drainage with Soft Silicone Drain 18Fr, 100cm, 500ml Collecting Bag EUDAMED
- Device Name
- Silicone thoracic catheter, Straight, 8 FR, 500 mm EUDAMED
- Model / Reference
- FR-76081 EUDAMEDFR-76184 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04716770761848 EUDAMED
- Basic UDI-DI
- 4716770FR07600GD EUDAMED
- Direct Marketing DI
- 04716770761848 EUDAMED
- EMDN Code
- A0601010401 THORACIC DRAINAGES (STRAIGHT AND ANGLED) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
Passive Drainage with Soft Silicone Drain 18Fr, 100cm, 500ml Collecting Bag by Besmed Health Business Corp. — Class IIa — MDR — listed in EUDAMED
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 | 4716770FR07600GD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
- EUDAMED SRN
- TW-MF-000007246
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (1)
- EUDAMED ac8390cb-039a-4f48-818e-76b22a43ae9d 61 fields · synced Oct 6, 2026