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R2P Metacross RX
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BD-P30080ERModel Kaneka PTA Balloon Dilatation Catheters
Identity
- Trade Name
- R2P Metacross RX EUDAMEDFDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- R2P Metacross RX EUDAMEDR2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm). FDA UDI
- Model / Reference
- BD-P30080ER EUDAMEDFDA UDIKaneka PTA Balloon Dilatation Catheters EUDAMED
- Description
- R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm). FDA UDI
Identifiers
- Catalog Number
- BD-P30080ER FDA UDI
- Primary DI / UDI-DI
- 04540778166653 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04540778166653 EUDAMED4993478KNK0013Q EUDAMED
- 510(k) Number
- K163479 FDA UDI
- FDA Product Code
- LIT FDA UDI
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Market of Registration
- Germany 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
R2P Metacross RX by KANEKA Corporation — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04540778166653 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04540778166653 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- KANEKA Corporation
- EUDAMED SRN
- JP-MF-000022143
- Authorised Representative
- Kaneka Medical Europe N.V. BE-AR-000010091
Sources (3)
- EUDAMED a413ff8f-905f-434c-b426-dcd5b2da0b2a 61 fields · synced Jun 19, 2026
- EUDAMED d825a808-6d9c-47e0-8e49-4903d9a87a20 61 fields · synced May 19, 2026
- FDA UDI dc25ed61-9691-42b4-a9d1-1495099eac09 38 fields · synced May 29, 2026