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Silicone Penrose Straight Drain Tube
EUDAMEDClass IIa (EU MDR)
Ref 2011-0020Ref 2011-0045Ref 2011-0025
Identity
- Trade Name
- Silicone Penrose Straight Drain Tube EUDAMED
- Device Name
- Silicone Penrose Straight Drain Tube EUDAMED
- Model / Reference
- 2011-0020 EUDAMED2011-0045 EUDAMED2011-0025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961934752 EUDAMED04710961934783 EUDAMED04710961934769 EUDAMED
- Basic UDI-DI
- B-04710961934752 EUDAMEDB-04710961934783 EUDAMEDB-04710961934769 EUDAMED
- EMDN Code
- A06010199 VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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 Straight Drain Tube 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-04710961934752 | 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 (3)
- EUDAMED 233d9d7f-6b02-4a4a-b0dd-02d8f1b8217a 61 fields · synced Jul 13, 2026
- EUDAMED 9472892f-62ed-4f5f-85b6-ad9eb919537f 61 fields · synced May 18, 2026
- EUDAMED 1f56bf63-6984-4347-b86c-b43a34e8fbde 61 fields · synced May 18, 2026