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Soft Silicone Drain, Straight, 10FR, 500mm
EUDAMEDClass IIa (EU MDR)
Ref FR-76101Model FR-76081
Identity
- Trade Name
- Soft Silicone Drain, Straight, 10FR, 500mm EUDAMED
- Device Name
- Silicone thoracic catheter, Straight, 8 FR, 500 mm EUDAMED
- Model / Reference
- FR-76081 EUDAMEDFR-76101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04716770761015 EUDAMED
- Basic UDI-DI
- 4716770FR07600GD EUDAMED
- Direct Marketing DI
- 04716770761015 EUDAMED
- EMDN Code
- A0601010401 THORACIC DRAINAGES (STRAIGHT AND ANGLED) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Croatia 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
Soft Silicone Drain, Straight, 10FR, 500mm by Besmed Health Business Corp. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 5bb6b221-964e-435b-b29a-a5c0804524ce 61 fields · synced Oct 6, 2026