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Phaco Accessories Set 21G
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PA603953
by Medicel AG
Identity
- Trade Name
- Phaco Accessories Set 21G EUDAMEDPhaco Accessory Set FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Phaco Accessories Set EUDAMEDPA603953 COOLFLOW 21G Sleeve, clear FDA UDI
- Model / Reference
- PA603953 EUDAMEDFDA UDI
- Description
- PA603953 COOLFLOW 21G Sleeve, clear FDA UDI
Identifiers
- Catalog Number
- PA603953 FDA UDI
- Primary DI / UDI-DI
- 07630055243768 EUDAMEDFDA UDI
- Basic UDI-DI
- 076300552PASU033D EUDAMED
- Direct Marketing DI
- 07630055243768 EUDAMED
- FDA Product Code
- KYG FDA UDI
- EMDN Code
- Q020699 PHACOEMULSIFICATION DEVICES - OTHER 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
- 886.4360 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Phaco Accessories Set 21G by Medicel AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 076300552PASU033D | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Medicel AG
- EUDAMED SRN
- CH-MF-000016652
- Authorised Representative
- Rudolf Riester GmbH DE-AR-000015844
Sources (2)
- EUDAMED 508ca79a-bf7c-4168-bbf6-8be5ed45c308 61 fields · synced Jun 18, 2026
- FDA UDI 03484105-e607-4466-9f85-a1c257acec31 35 fields · synced May 25, 2026