← Back to catalogue
Instaform Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref Multiple IFF03 catalogue numbersModel IFF03 Instaform Kit Series
Identity
- Trade Name
- Instaform Kit EUDAMEDInstaform FDA UDI
- Generic Name
- Patient positioning foam mould kit FDA UDI
- Device Name
- Instaform Kit EUDAMEDFDA UDI
- Model / Reference
- IFF03 Instaform Kit Series EUDAMEDMultiple IFF03 catalogue numbers EUDAMED1 FDA UDI
- Description
- Instaform Kit FDA UDI
Identifiers
- Catalog Number
- IFF03 FDA UDI
- Primary DI / UDI-DI
- 00628341930321 EUDAMEDFDA UDI
- Basic UDI-DI
- 62834193068M EUDAMED
- 510(k) Number
- K122888 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient positioning foam mould kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- France 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
Yes
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
Instaform Kit by CDR Systems 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 | 62834193068M | 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
- CDR Systems Inc.
- EUDAMED SRN
- CA-MF-000051790
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 5e0c8817-d287-4c5b-8fbd-c16e9705c3d4 61 fields · synced Jun 18, 2026
- FDA UDI 32666661-0faa-460e-9517-a11996e9c999 36 fields · synced May 30, 2026