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Disposable Subdermal Needle Electrode, twisted
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SO-ELD1320Ref NE-220BRef TE/S49-438Ref SO-ELS1720Ref TE/S50722-002Ref TE/S50722-001Ref NE-125BRef SO-ELS1320Ref S56-638Ref TE/S50722-005Ref NE-110BRef TE/S50722-003Ref TE/S50723-002Ref TE/S50722-004Ref TE/S49-638Ref NE-115BRef 302888-000Ref 019-475800
Identity
- Trade Name
- Disposable Subdermal Needle Electrode, twisted EUDAMEDDisposable Subdermal Needle Electrode EUDAMEDCadwell FDA UDICNS - Premier Vision FDA UDINatus FDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- Disposable Subdermal Needle Electrodes EUDAMEDDisposable Subdermal Needle Electrode, twisted EUDAMEDDisposable Subdermal Needle Electrode EUDAMEDDisposable Subdermal Needle Electrode; 7x0.3mm 2.5m wire 4x6 colors 24pcs FDA UDIDisposable Subdermal Needle Electrode, twisted, 13x0.38mm 1.5m 6 lead twisted wire 10sets FDA UDIDisposable Subdermal Needle Electrode, 12x0.4mm needle, 1m wire, 4x6 colors, 24pcs FDA UDI
- Model / Reference
- SO-ELD1320 EUDAMEDNE-220B EUDAMEDTE/S49-438 EUDAMEDSO-ELS1720 EUDAMEDTE/S50722-002 EUDAMEDTE/S50722-001 EUDAMEDNE-125B EUDAMEDSO-ELS1320 EUDAMEDS56-638 EUDAMEDFDA UDITE/S50722-005 EUDAMEDNE-110B EUDAMEDTE/S50722-003 EUDAMEDTE/S50723-002 EUDAMEDTE/S50722-004 EUDAMED302888-000 EUDAMEDFDA UDI019-475800 EUDAMEDFDA UDITE/S49-638 EUDAMEDNE-115B EUDAMED
- Description
- Disposable Subdermal Needle Electrode; 7x0.3mm 2.5m wire 4x6 colors 24pcs FDA UDIDisposable Subdermal Needle Electrode, twisted, 13x0.38mm 1.5m 6 lead twisted wire 10sets FDA UDIDisposable Subdermal Needle Electrode, 12x0.4mm needle, 1m wire, 4x6 colors, 24pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375865385 EUDAMED08720791371319 EUDAMED08718375863619 EUDAMED08718375865378 EUDAMED08718375866757 EUDAMED08718375866733 EUDAMED08720791371272 EUDAMED08718375865361 EUDAMED08720791371418 EUDAMEDFDA UDI08718375866818 EUDAMED08720791371210 EUDAMED08718375866771 EUDAMED08718375866856 EUDAMED08718375866795 EUDAMED08720791376543 EUDAMEDFDA UDI08718375867143 EUDAMEDFDA UDI08718375863626 EUDAMED08720791371234 EUDAMED
- Basic UDI-DI
- B-08718375865385 EUDAMEDB-08720791371319 EUDAMEDB-08718375863619 EUDAMEDB-08718375865378 EUDAMEDB-08718375866757 EUDAMEDB-08718375866733 EUDAMEDB-08720791371272 EUDAMEDB-08718375865361 EUDAMEDB-08720791371418 EUDAMEDB-08718375866818 EUDAMEDB-08720791371210 EUDAMEDB-08718375866771 EUDAMEDB-08718375866856 EUDAMEDB-08718375866795 EUDAMEDB-08718375863626 EUDAMEDB-08720791371234 EUDAMEDB-08720791376543 EUDAMEDB-08718375867143 EUDAMED
- FDA Product Code
- GXZ FDA UDIIKT FDA UDI
- EMDN Code
- N01010202 EEG EXTRACRANIC ELECTRODES EUDAMED
- GMDN Term
- Subdermal needle electrode FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1350 FDA UDI890.1385 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMED
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 UDIFDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 7 Millimeter FDA UDIOuter Diameter — 0.3 Millimeter FDA UDINeedle Gauge — 30 Gauge FDA UDIOuter Diameter — 0.38 Millimeter FDA UDILength — 13 Millimeter FDA UDILength — 12 Millimeter FDA UDIOuter Diameter — 0.40 Millimeter FDA UDI
Disposable Subdermal Needle Electrode, twisted by Technomed Europe — 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-08718375865385 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Technomed Europe
- EUDAMED SRN
- NL-MF-000000064
Sources (21)
- EUDAMED ead53894-89f8-4145-aa50-8d00486acc4c 61 fields · synced Aug 2, 2026
- EUDAMED 6a089dc6-c423-4a72-9aac-778d75b1a425 61 fields · synced May 16, 2026
- EUDAMED d0241983-ac64-4728-83c8-8e8a5f5bf11a 61 fields · synced May 16, 2026
- EUDAMED d6acb65c-0fb4-4d73-9eec-dce27e56493a 61 fields · synced May 16, 2026
- EUDAMED 5a980617-434f-46a7-8cca-d4cf86d36267 61 fields · synced May 17, 2026
- EUDAMED 34b5b580-b239-46af-943a-a39a0e41d469 61 fields · synced May 18, 2026
- EUDAMED ffc57ffa-c818-400d-8ed0-d51f1a209209 61 fields · synced May 18, 2026
- EUDAMED cabcbcfa-ecb0-4845-b25e-6b7793c4647f 61 fields · synced May 18, 2026
- EUDAMED e1770305-66c2-436b-9dd7-65903d151dfc 61 fields · synced May 18, 2026
- EUDAMED 47228fe5-5a8f-4402-8407-32eb630644fb 61 fields · synced May 18, 2026
- EUDAMED f80f0c3b-13d4-4855-a5a2-52489ec49e48 61 fields · synced May 18, 2026
- EUDAMED 3a5f5c6f-b418-4b4d-8453-ff4d5bfd57db 61 fields · synced May 18, 2026
- EUDAMED a6d1739e-98c5-4012-b82a-322668e3fbd9 61 fields · synced May 18, 2026
- EUDAMED cf9fd389-f716-455c-883b-9107ffaf4631 61 fields · synced May 19, 2026
- FDA UDI 29a7ac7d-9ae7-47c5-b1c1-0724f22e405b 35 fields · synced May 30, 2026
- FDA UDI f039467c-5965-4447-9c63-88bbbed44de5 35 fields · synced May 30, 2026
- FDA UDI 80c8b268-0a85-48d0-ae3f-d7dfb8a7a6d8 35 fields · synced May 30, 2026
- EUDAMED 509c4dc1-560c-4131-bc62-de35a96cc0a5 61 fields · synced Jul 8, 2026
- EUDAMED 54c26872-6abd-46b6-9ece-f91fcefca4de 61 fields · synced Jul 11, 2026
- EUDAMED be55c792-9c4e-4d9f-8b1b-5694b8e42dc2 61 fields · synced Jul 16, 2026
- EUDAMED 0c247d75-2b79-4fc7-8ecd-59e4d237b145 61 fields · synced Jul 29, 2026