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DuploTip
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 0601138Ref 0601136Ref SA374003004444Ref SA375003005555
Identity
- Trade Name
- DuploTip EUDAMEDFDA UDINordson Medical FDA UDI
- Generic Name
- Open-surgery adhesive/sealant applicator, dual-channel FDA UDIFibrin sealant biochemical preparation/application kit, endoscopic FDA UDI
- Device Name
- Dual Lumen Cannula EUDAMEDDuel Lumen Cannula EUDAMEDDual Lumen Catheter EUDAMEDDuplotip with Snap Lock, 20G x 10cm FDA UDIDuploTip with Snap Lock, 5mm x 32cm FDA UDI
- Model / Reference
- 0601138 EUDAMEDFDA UDI0601136 EUDAMEDFDA UDISA374003004444 EUDAMEDSA375003005555 EUDAMED
- Description
- Duplotip with Snap Lock, 20G x 10cm FDA UDIDuploTip with Snap Lock, 5mm x 32cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815634021266 EUDAMEDFDA UDI20815634020515 EUDAMED20815634020522 EUDAMED00815634020511 EUDAMEDFDA UDI10815634020549 EUDAMED
- Basic UDI-DI
- B-00815634021266 EUDAMEDB-20815634020515 EUDAMEDB-20815634020522 EUDAMEDB-00815634020511 EUDAMEDB-10815634020549 EUDAMED
- 510(k) Number
- K033589 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Open-surgery adhesive/sealant applicator, dual-channel FDA UDIFibrin sealant biochemical preparation/application kit, endoscopic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- Belgium 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DuploTip by Micromedics, Inc. — 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-00815634021266 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Micromedics, Inc.
- EUDAMED SRN
- US-MF-000018365
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (7)
- EUDAMED d2c60dcc-d756-4d67-81cd-2c21daf5f55a 61 fields · synced Jul 22, 2026
- EUDAMED 38165995-47a9-475c-a86a-7f42ade4db96 61 fields · synced May 17, 2026
- EUDAMED cebb82c1-ba84-428c-b32b-91b5ea446f2f 61 fields · synced May 17, 2026
- FDA UDI e29f057d-3f4a-4446-8b6b-3f00f0922829 34 fields · synced May 30, 2026
- FDA UDI 327acded-e05a-4646-a767-febec5c205d2 34 fields · synced May 30, 2026
- EUDAMED 89ffd58e-7fcb-472f-ad64-7968ddaf7e2c 61 fields · synced Jul 11, 2026
- EUDAMED 8cc1fac4-4cb3-4412-ad12-1ebb33941d25 61 fields · synced Jul 21, 2026