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Silicone Penrose Drain Tube
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2010-1425Ref 2010-1408Ref 2010-0425Ref 2010-0406Ref 2010-0412Ref 2010-0405Ref 2010-0415Ref 2010-0408
Identity
- Trade Name
- Silicone Penrose Drain Tube EUDAMEDFDA UDI
- Generic Name
- Surgical capillary wound drain, luminal, synthetic polymer FDA UDI
- Device Name
- Silicone Penrose Drain Tube EUDAMED
- Model / Reference
- 2010-1425 EUDAMED2010-1408 EUDAMED2010-0425 EUDAMED2010-0406 EUDAMED2010-0412 EUDAMED2010-0405 EUDAMED2010-0415 EUDAMED2010-0408 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04711182605445 EUDAMED04710961934622 EUDAMED04711182606527 EUDAMED34710961934562 EUDAMED04710961934561 EUDAMED04710961934592 EUDAMED04710961934554 EUDAMED34710961934593 EUDAMED34710961934555 EUDAMED04711182605568 EUDAMED14710961934575 EUDAMEDFDA UDI34710961934579 EUDAMED
- Basic UDI-DI
- B-04711182605445 EUDAMEDB-04710961934622 EUDAMEDB-04711182606527 EUDAMEDB-34710961934562 EUDAMEDB-04710961934561 EUDAMEDB-04710961934592 EUDAMEDB-04710961934554 EUDAMEDB-34710961934593 EUDAMEDB-34710961934555 EUDAMEDB-04711182605568 EUDAMEDB-14710961934575 EUDAMEDB-34710961934579 EUDAMED
- FDA Product Code
- GCD FDA UDI
- EMDN Code
- A06010199 VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER EUDAMED
- GMDN Term
- Surgical capillary wound drain, luminal, synthetic polymer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Market of Registration
- Netherlands EUDAMEDMalta EUDAMEDCzechia EUDAMEDFrance EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Silicone Penrose Drain Tube by Fortune Medical Instrument Corp. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04711182605445 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (13)
- EUDAMED 043361ed-a7da-40c8-971f-ebeab692a3d7 61 fields · synced Aug 2, 2026
- EUDAMED 4982f6ff-b2f4-41f4-9491-3957ea61d417 61 fields · synced May 11, 2026
- EUDAMED 92d03bdd-1227-4d68-aa61-d8836699c771 61 fields · synced May 16, 2026
- EUDAMED 6f148e6d-c784-4c60-8715-1999f0af9a0f 61 fields · synced May 17, 2026
- EUDAMED 02911942-3cee-4792-89a1-f976468920f3 61 fields · synced May 17, 2026
- EUDAMED 3001d357-fe9b-4c61-aa03-3952af474949 61 fields · synced May 17, 2026
- EUDAMED fdb34a62-a923-47b8-a1f8-62fb11f3a448 61 fields · synced May 19, 2026
- EUDAMED 801abe67-e8f6-4d28-860a-e3a4052e7372 61 fields · synced May 19, 2026
- EUDAMED 7a4d4598-ad81-4371-807b-e57f8d3779eb 61 fields · synced May 19, 2026
- EUDAMED 0e6fe4d6-f87c-4711-80ac-73d244cda8a4 61 fields · synced May 19, 2026
- EUDAMED 13ba6abc-82cf-4f38-9600-fea5ef2c79bd 61 fields · synced May 19, 2026
- EUDAMED a6c00659-baf2-4a1a-9692-8c22c3b79a00 61 fields · synced May 19, 2026
- FDA UDI 94743673-1656-4e7c-86cd-cd5cd312fafc 32 fields · synced May 30, 2026