Identity
- Trade Name
- Penrose tube, Flat, OD:12 mm, L:300 mm EUDAMED
- Device Name
- Silicone Penrose tube, Flat, OD:12 mm, L:300 mm EUDAMED
- Model / Reference
- PN-84212 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-PN-8421269 EUDAMED
- Basic UDI-DI
- B-PN-8421269 EUDAMED
- EMDN Code
- A0601010403 FLAT AND LAMELLAR DRAINAGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Closed-wound drain, non-bioabsorbable
Penrose tube, Flat, OD:12 mm, L:300 mm by Besmed Health Business Corp. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-PN-8421269 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
- EUDAMED SRN
- TW-MF-000007246
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 6a328d34-66e4-464b-9b95-15b6d9977b47 61 fields · synced Jun 19, 2026