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Silicone Penrose Drain Tube W/ Secure-Clip
EUDAMEDClass IIa (EU MDR)
Ref 2010-6405
Identity
- Trade Name
- Silicone Penrose Drain Tube W/ Secure-Clip EUDAMED
- Device Name
- Silicone Penrose Drain Tube W/ Secure-Clip EUDAMED
- Model / Reference
- 2010-6405 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182604899 EUDAMED
- Basic UDI-DI
- B-04711182604899 EUDAMED
- EMDN Code
- A06010199 VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Silicone Penrose Drain Tube W/ Secure-Clip by Fortune Medical Instrument Corp. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-04711182604899 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 04763654-694b-4a72-bb66-8af8887d615e 61 fields · synced Jun 18, 2026