Retrobulbar Needle Atkinson 25G x 38mm
EUDAMEDFDA UDIClass IIa (EU MDR)
by Aktive Srl
Identity
- Trade Name
- Retrobulbar Needle Atkinson 25G x 38mm EUDAMEDFDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Needles and Cannulae / Aghi e Cannule EUDAMEDRetrobulbar Needle Atkinson 25G x 38mm FDA UDI
- Model / Reference
- Needles and Cannulae / Aghi e Cannule EUDAMED1637 EUDAMEDFDA UDI
- Description
- Retrobulbar Needle Atkinson 25G x 38mm FDA UDI
Identifiers
- Catalog Number
- 1637 FDA UDI
- Primary DI / UDI-DI
- 08052276012883 EUDAMEDFDA UDI
- Basic UDI-DI
- 8052276FT0001ID10KM EUDAMED
- Unit of Use DI
- 08058340226606 EUDAMED
- FDA Product Code
- HMX FDA UDI
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Retrobulbar Needle Atkinson 25G x 38mm by Aktive Srl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
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- SURGISTAR — Surgistar Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8052276FT0001ID10KM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Aktive Srl
- EUDAMED SRN
- IT-MF-000007813
Sources (2)
- EUDAMED 1a8b9617-36bd-4538-8ffa-7c1ad88beadb 61 fields · synced Jul 29, 2026
- FDA UDI b5b20451-cf19-4060-a9bc-743c2441a809 36 fields · synced May 30, 2026