Identity
- Trade Name
- CadWell EUDAMEDFDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- Disposable Subdermal Needle Electrodes(Single) EUDAMED
- Model / Reference
- 302354-000-060 EUDAMEDFDA UDI1324 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16955739013245 EUDAMEDFDA UDI
- Basic UDI-DI
- B-16955739013245 EUDAMED
- 510(k) Number
- K072276 FDA UDI
- FDA Product Code
- GXZ FDA UDI
- EMDN Code
- Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
- GMDN Term
- Subdermal needle electrode FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1350 FDA UDI
- Market of Registration
- Italy 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
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
Ethylene Oxide FDA UDI
CadWell by Xi'an Friendship Medical Electronics Co., Ltd. — 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-16955739013245 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Xi'an Friendship Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000004202
- Authorised Representative
- Friendship Europe ApS DK-AR-000001593
Sources (2)
- EUDAMED 2d55c0c2-0d87-4587-b5a3-40f3e01e89e8 61 fields · synced May 30, 2026
- FDA UDI f610aa1b-be8a-4294-a694-f13827c82c3c 33 fields · synced May 30, 2026