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injeTAK Adjustable Tip Needle (70 cm)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref DIS201-EModel DIS199-E
Identity
- Trade Name
- injeTAK Adjustable Tip Needle (70 cm) EUDAMED
- Device Name
- injeTAK Adjustable Tip Needle (35 cm) EUDAMED
- Model / Reference
- DIS199-E EUDAMEDDIS201-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00627825000147 EUDAMED
- Basic UDI-DI
- 062782507NM EUDAMED
- EMDN Code
- A0199 NEEDLES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hypodermic needle, single-use
injeTAK Adjustable Tip Needle (70 cm) by Laborie Medical Technologies Corp. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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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 | K241523 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 062782507NM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Laborie Medical Technologies Corp.
- EUDAMED SRN
- US-MF-000022925
- Authorised Representative
- Medical Measurement Systems B.V. NL-AR-000010438
Sources (2)
- EUDAMED fdda888a-2034-4f84-947c-01cf8bcd3bb5 61 fields · synced Oct 6, 2026
- FDA 510(k) K241523 1 fields · synced May 18, 2026