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Injection Pen Needle
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 0.25×6mm/31G ETWRef 0.23×4mm/32G ETWRef 0.25×8mm/31G ETWRef 0.20×4.5mm/33G ETWRef 0.20×4mm/33G ETWRef 0.30×8mm/30G ETWRef 0.30×6mm/30G ETW
Identity
- Trade Name
- Injection Pen Needle EUDAMED
- Device Name
- Injection Pen Needle EUDAMED
- Model / Reference
- 0.25×6mm/31G ETW EUDAMED0.23×4mm/32G ETW EUDAMED0.25×8mm/31G ETW EUDAMED0.20×4.5mm/33G ETW EUDAMED0.20×4mm/33G ETW EUDAMED0.30×8mm/30G ETW EUDAMED0.30×6mm/30G ETW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971953351314 EUDAMED16971953352670 EUDAMED16971953351321 EUDAMED16971953350348 EUDAMED16971953350355 EUDAMED16971953350386 EUDAMED16971953351345 EUDAMED16971953351307 EUDAMED16971953351291 EUDAMED
- Basic UDI-DI
- 697195335321202FMI3160EYC EUDAMED697195335321202FMI3240EY9 EUDAMED697195335321202FMI3180EYN EUDAMED697195335321202FMI3345EYX EUDAMED697195335321202FMI3340EYG EUDAMED697195335321202FMI3080EYF EUDAMED697195335321202FMI3060EY5 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Injection Pen Needle by Gangan Medical Technology Jiangsu Co., LTD — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192464 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697195335321202FMI3160EYC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Gangan Medical Technology Jiangsu Co., LTD
- EUDAMED SRN
- CN-MF-000007635
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (10)
- EUDAMED 06619e56-66c6-4de6-89aa-77178bd33fb0 61 fields · synced Aug 4, 2026
- EUDAMED de87eb32-6da6-40fb-9e39-a62fb62f3bb6 61 fields · synced May 17, 2026
- EUDAMED bbd4a862-a68a-4c39-a49c-1c2dc68bb86b 61 fields · synced May 17, 2026
- EUDAMED c9c6efa6-6e90-468b-897d-f8c4f906a7cf 61 fields · synced May 17, 2026
- EUDAMED 1c3f0e6e-c765-4c49-89f7-0df095cc4568 61 fields · synced May 17, 2026
- EUDAMED 76e55641-0f4e-4350-b5d6-5e792be58b5e 61 fields · synced May 17, 2026
- EUDAMED 2b048613-7b18-4322-bf4c-0fc8d18ff7c7 61 fields · synced May 18, 2026
- EUDAMED 3dfc6891-45cb-46b1-a41f-80d89ad35e9e 61 fields · synced May 18, 2026
- EUDAMED cbfe1071-aa59-4f7b-a693-5d417affec15 61 fields · synced May 19, 2026
- FDA 510(k) K192464 1 fields · synced May 18, 2026