← Back to catalogue
ARC Sterile Radial Compression Device
EUDAMEDFDA UDIClass I (EU MDR)
Ref RCB-0048
Identity
- Trade Name
- ARC Sterile Radial Compression Device EUDAMEDARC Adjustable Radial Cuff FDA UDI
- Generic Name
- Radial artery compression device FDA UDI
- Device Name
- ARC Adjustable Radial Cuff- Medium FDA UDI
- Model / Reference
- RCB-0048 EUDAMEDFDA UDI
- Description
- ARC Adjustable Radial Cuff- Medium FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811331011333 EUDAMED00811331011340 FDA UDI
- Basic UDI-DI
- 081133101RCB-0048JE EUDAMED
- 510(k) Number
- K040208 FDA UDI
- FDA Product Code
- FRO FDA UDI
- EMDN Code
- W0202029085 VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Radial artery compression device FDA UDI
Classification
- Device Class
- Class I EUDAMEDU 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ARC Sterile Radial Compression Device by Tz Medical, Inc. — Class I — 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 | 081133101RCB-0048JE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TZ Medical inc
- EUDAMED SRN
- US-MF-000027311
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED a27ff626-6147-4950-8fa7-1cb39438fdc2 61 fields · synced Oct 6, 2026
- FDA UDI a512b3c4-c67b-4f42-9601-dd574f642bb7 34 fields · synced May 30, 2026