← Back to catalogue
Pro-Form EVA Plus
EUDAMEDFDA UDIClass I (EU MDR)
Ref 7000190Ref 7000190R1PPRef 7000190R2Ref 7000190R1Ref 7000192R1Ref 7000191R2PPRef 7000190PP1Ref 7000192R2Ref 7000192Ref 7000190R2PP
Identity
- Trade Name
- Pro-Form EVA Plus EUDAMEDProform FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Vacuum Forming Materials EUDAMEDEVA Plus .080 120mm Round 300Ea FDA UDIEVA Plus .080 300Ea FDA UDIEVA Plus .040, 120mm Round 300Ea FDA UDIEVA Plus .040 300Ea FDA UDIEVA Plus .080, 125mm Round 300Ea FDA UDIEVA Plus .040, 125mm Round 300Ea FDA UDI
- Model / Reference
- 7000190 EUDAMEDFDA UDI7000192R2 EUDAMEDFDA UDI7000192 EUDAMEDFDA UDI7000190R2 EUDAMEDFDA UDI7000192R1 EUDAMEDFDA UDI7000190R1 EUDAMEDFDA UDI7000190R1PP EUDAMED7000191R2PP EUDAMED7000190PP1 EUDAMED7000190R2PP EUDAMED
- Description
- EVA Plus .080 120mm Round 300Ea FDA UDIEVA Plus .080 300Ea FDA UDIEVA Plus .040, 120mm Round 300Ea FDA UDIEVA Plus .040 300Ea FDA UDIEVA Plus .080, 125mm Round 300Ea FDA UDIEVA Plus .040, 125mm Round 300Ea FDA UDI
Identifiers
- Catalog Number
- 7000192R2 FDA UDI7000192 FDA UDI7000190R2 FDA UDI7000190 FDA UDI7000192R1 FDA UDI7000190R1 FDA UDI
- Primary DI / UDI-DI
- ++H66870001901 EUDAMED++H6687000190R1PP1 EUDAMED++H6687000190R21 EUDAMED++H6887000190R11 EUDAMED++H6687000192R11 EUDAMED++H6687000191R2PP1 EUDAMED++H6687000190PP1 EUDAMED++H6687000192R21 EUDAMED++H66870001921 EUDAMED++H6687000190R2PP1 EUDAMEDH6687000192R21 FDA UDIH66870001921 FDA UDIH6687000190R21 FDA UDIH66870001901 FDA UDIH6687000192R11 FDA UDIH6687000190R11 FDA UDI
- Basic UDI-DI
- ++H668VFM00158 EUDAMED
- FDA Product Code
- MQC FDA UDIEBH FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIU FDA UDI
- Regulation Number
- 872.3670 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pro-Form EVA Plus by Keystone Industries — 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 | ++H668VFM00158 | 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
- Keystone Industries
- EUDAMED SRN
- US-MF-000020203
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (16)
- EUDAMED c122be8e-2d70-4d31-8698-f223ef51397e 61 fields · synced Sep 18, 2026
- FDA UDI 8f961004-92b8-49d4-bd15-b386de1206b1 36 fields · synced May 29, 2026
- FDA UDI 2f87804e-5eeb-4f3c-bfa4-5bca2d19b605 36 fields · synced May 29, 2026
- FDA UDI 5602f5c6-31cb-4ac9-b0ce-85796df6b076 36 fields · synced May 30, 2026
- FDA UDI 3366ae4d-5a01-4b39-9852-313330305ef0 36 fields · synced May 30, 2026
- FDA UDI 656dc586-33ea-4950-bffb-14dbe6087e6b 36 fields · synced May 30, 2026
- FDA UDI d1705767-28e1-4be2-9b9b-75313474f4a9 36 fields · synced May 30, 2026
- EUDAMED db45bddb-af8b-49f1-ae58-72ba011adc45 61 fields · synced Jun 20, 2026
- EUDAMED c30d4e09-a027-42fb-8195-327596ce2a70 61 fields · synced Jul 11, 2026
- EUDAMED 6305ec51-d153-4e5e-98fa-d961e01d3875 61 fields · synced Jul 11, 2026
- EUDAMED 38056716-6c11-4ca2-841c-ac6427112a81 61 fields · synced Jul 21, 2026
- EUDAMED 9dda9d9c-489c-45fd-906f-a28f5b80c7fc 61 fields · synced Jul 22, 2026
- EUDAMED dacd81f6-fc18-44fc-ba3b-d7059d676c5f 61 fields · synced Jul 26, 2026
- EUDAMED cb83b411-9335-48c3-815c-618ae2246c4e 61 fields · synced Jul 30, 2026
- EUDAMED 61924db9-2091-4f49-a78e-f5d38500b60d 61 fields · synced Jul 30, 2026
- EUDAMED 9dbbffff-65dd-489e-8258-c25816b1790c 61 fields · synced Jul 30, 2026