Identity
- Trade Name
- C-Arm Drape EUDAMEDExact Medical Manufacturing, Inc. FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- C-Arm Drape EUDAMEDUniversal Mini C-Arm Drape 48"x84" FDA UDI
- Model / Reference
- AM3045 EUDAMEDFDA UDI
- Description
- Universal Mini C-Arm Drape 48"x84" FDA UDI
Identifiers
- Catalog Number
- AM3045 FDA UDI
- Primary DI / UDI-DI
- 06975085709503 EUDAMEDFDA UDI
- Basic UDI-DI
- 697508570EC04J7 EUDAMED
- 510(k) Number
- K101689 FDA UDI
- FDA Product Code
- KKX FDA UDI
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
C-Arm Drape by Exact Medical Manufacturing, 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 | 697508570EC04J7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Exact Medical Manufacturing, Inc
- EUDAMED SRN
- CN-MF-000001406
- Authorised Representative
- Exact Medical Manufacturing B.V. NL-AR-000000452
Sources (2)
- EUDAMED f29fc177-e280-40f6-8bdc-568c8167f5e1 61 fields · synced Jun 19, 2026
- FDA UDI bdcdb176-0226-4435-9b2b-e80e0b463431 35 fields · synced May 30, 2026