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Silicone Penrose tube, Round, OD:12mm, L:500 mm
EUDAMEDClass IIa (EU MDR)
Ref PN-84512Model PN-84306
Identity
- Trade Name
- Silicone Penrose tube, Round, OD:12mm, L:500 mm EUDAMED
- Device Name
- Silicone Penrose tube, Round, OD:6mm, L:300mm EUDAMED
- Model / Reference
- PN-84306 EUDAMEDPN-84512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04716770845128 EUDAMED
- Basic UDI-DI
- 4716770PN08400KY EUDAMED
- Direct Marketing DI
- 04716770845128 EUDAMED
- EMDN Code
- A0601010403 FLAT AND LAMELLAR DRAINAGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Category: Closed-wound drain, non-bioabsorbable
Silicone Penrose tube, Round, OD:12mm, L:500 mm by Besmed Health Business Corp. — Class IIa — 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 | 4716770PN08400KY | 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 b73d0269-32b6-468b-b240-00603a2ad024 61 fields · synced Oct 6, 2026