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TECA ELITE Disposable Concentric Violet Needle, 75mm, .64(23G) diameter, 25 per…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref S53159
Identity
- Trade Name
- TECA ELITE Disposable Concentric Violet Needle, 75mm, .64(23G) diameter, 25 per Pk EUDAMEDTeca Elite FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- TECA® Elite Disposable Concentric Needle Electrodes EUDAMEDTECA ELITE Disposable Concentric Violet Needle, 75mm, .64(23G) diameter, 25 per Pk FDA UDI
- Model / Reference
- S53159 EUDAMEDFDA UDI
- Description
- TECA ELITE Disposable Concentric Violet Needle, 75mm, .64(23G) diameter, 25 per Pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830017527 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00001DM EUDAMED
- Unit of Use DI
- 00382830062862 EUDAMED
- 510(k) Number
- K112034 FDA UDI
- FDA Product Code
- IKT FDA UDI
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1385 FDA UDI
- Market of Registration
- Ireland 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
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
Yes
FDA UDI
TECA ELITE Disposable Concentric Violet Needle, 75mm, .64(23G) diameter, 25 per… by Natus Manufacturing Limited — Class IIa — MDR, FDA UDI — listed in…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 038283NA00001DM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Natus Manufacturing Limited
- EUDAMED SRN
- IE-MF-000000799
Sources (2)
- EUDAMED 97306db8-9173-430a-bdb8-1a53a51ab488 61 fields · synced Jul 22, 2026
- FDA UDI 5d2133cc-6336-4c5a-b2af-d336537d5630 34 fields · synced May 27, 2026