Microinsulated Needle
EUDAMEDFDA UDIClass IIb (EU MDR)
by Cynosure LLC
Identity
- Trade Name
- MICROINSULATED NEEDLE EUDAMEDFDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- MICROINSULATED NEEDLE EUDAMEDMICROINSULATED NEEDLES STERILE, 50 PCS FDA UDI
- Model / Reference
- H137 EUDAMEDFDA UDI
- Description
- MICROINSULATED NEEDLES STERILE, 50 PCS FDA UDI
Identifiers
- Catalog Number
- H137 FDA UDI
- Primary DI / UDI-DI
- 00841494106751 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841494106751 EUDAMED
- FDA Product Code
- JOS FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Microinsulated Needle by Cynosure, LLC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00841494106751 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Cynosure LLC
- EUDAMED SRN
- US-MF-000010200
- Authorised Representative
- Cynosure B.V. NL-AR-000009566
Sources (2)
- EUDAMED 3e1d0cd9-86e8-4dde-a707-71cb6ec89f6a 61 fields · synced Jun 19, 2026
- FDA UDI c837012f-1a36-4225-838d-44042f17096c 34 fields · synced May 30, 2026