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Checkpoint Surgical Head & Neck Nerve Stimulator
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 9394
Identity
- Trade Name
- Checkpoint Surgical Head & Neck Nerve Stimulator EUDAMEDCheckpoint Head & Neck FDA UDI
- Generic Name
- Nerve-locating system FDA UDI
- Device Name
- Checkpoint Surgical Head & Neck Nerve Stimulator EUDAMEDSurgical Nerve Stimulator/Locator FDA UDI
- Model / Reference
- 9394 EUDAMEDFDA UDI
- Description
- Surgical Nerve Stimulator/Locator FDA UDI
Identifiers
- Primary DI / UDI-DI
- B13093943 EUDAMEDB13093941 FDA UDI
- Basic UDI-DI
- B-B13093943 EUDAMED
- 510(k) Number
- K150005 FDA UDI
- FDA Product Code
- ETN FDA UDI
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
- GMDN Term
- Nerve-locating system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1820 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
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
No
FDA UDI
Category: Point aesthesiometer
Checkpoint Surgical Head & Neck Nerve Stimulator by Checkpoint Surgical, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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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-B13093943 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Checkpoint Surgical, Inc.
- EUDAMED SRN
- US-MF-000008429
- Authorised Representative
- WMDE B.V. NL-AR-000002062
Sources (2)
- EUDAMED 9785f521-9422-4ed2-bc76-df03bb9161cf 61 fields · synced Jul 16, 2026
- FDA UDI cc361bda-6602-4973-a07e-6b21dd9425c1 36 fields · synced May 30, 2026