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TECA ELITE Disposable Concentric Red Needle, 25mm, .3(30G) diameter, 25 per Pk
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref S53153
Identity
- Trade Name
- TECA ELITE Disposable Concentric Red Needle, 25mm, .3(30G) 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 Red Needle, 25mm, .3(30G) diameter, 25 per Pk FDA UDI
- Model / Reference
- S53153 EUDAMEDFDA UDI
- Description
- TECA ELITE Disposable Concentric Red Needle, 25mm, .3(30G) diameter, 25 per Pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830017480 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00001DM EUDAMED
- Unit of Use DI
- 00382830062824 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 Red Needle, 25mm, .3(30G) diameter, 25 per Pk by Natus Manufacturing Limited — Class IIa — MDR, FDA UDI — listed in EUDAMED…
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 32cf2c3b-4d5c-483e-91d5-a1e6443941b3 61 fields · synced Jul 8, 2026
- FDA UDI 773a637f-ab83-4afa-adec-9a213979f0d3 34 fields · synced May 30, 2026