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Bo-ject DHN Disp Electrode, 1"(25mm)x0.30mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 9013S0422
Identity
- Trade Name
- Bo-ject DHN Disp Electrode, 1"(25mm)x0.30mm EUDAMEDBoject FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- Bo-Ject® DHN Disposable Hypodermic Needle Electrodes EUDAMEDBo-ject Needle FDA UDI
- Model / Reference
- 9013S0422 EUDAMEDFDA UDI
- Description
- Bo-ject Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830042420 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00007DZ EUDAMED
- Unit of Use DI
- 00382830047319 EUDAMED
- FDA Product Code
- IKT FDA UDI
- EMDN Code
- Z12100485 ELECTROMYOGRAPHY INSTRUMENTS - CONSUMABLES 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
Yes
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
Bo-ject DHN Disp Electrode, 1"(25mm)x0.30mm by Natus Manufacturing Limited — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 038283NA00007DZ | 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 6ff5dba9-f699-4cf0-adab-8c5a15cac02b 61 fields · synced Jul 12, 2026
- FDA UDI a83466a1-4004-45e7-a46e-75cd6d1964a5 33 fields · synced May 30, 2026