← Back to catalogue
Gonad Apron Model RP643-STD
EUDAMEDFDA UDIClass I (EU MDR)
Ref RP6435M22SB12-PHModel RP
by MAVIG GmbH
Identity
- Trade Name
- Gonad Apron Model RP643-STD EUDAMEDRP FDA UDI
- Generic Name
- Gonad radiation shield FDA UDI
- Device Name
- RP-Radiation Protective Clothing Patient EUDAMEDRP - Radiation Protective Clothing Patient Gonad Apron Model RP643-STD FDA UDI
- Model / Reference
- RP EUDAMEDRP6435M22SB12-PH EUDAMEDFDA UDI
- Description
- RP - Radiation Protective Clothing Patient Gonad Apron Model RP643-STD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04251339906242 EUDAMEDFDA UDI
- Basic UDI-DI
- 4251339900486WB EUDAMED
- Direct Marketing DI
- 04251339906242 EUDAMED
- FDA Product Code
- IWO FDA UDIEAJ FDA UDI
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
- GMDN Term
- Gonad radiation shield FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.6500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Gonad Apron Model RP643-STD by MAVIG GmbH — 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 | 4251339900486WB | 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
- MAVIG GmbH
- EUDAMED SRN
- DE-MF-000006207
Sources (2)
- EUDAMED 0d7134d6-21d5-4749-8903-003aeb42494a 61 fields · synced Jul 9, 2026
- FDA UDI 158dff4e-3372-4bf3-b895-fdec4ef9d942 33 fields · synced May 30, 2026