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Intraoperative PU Probe Cover
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref E6361Model Intraoperative PU Probe Cover
Identity
- Trade Name
- Exact Medical Manufacturing, Inc. FDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDI
- Device Name
- Intraoperative PU Probe Cover EUDAMEDProbe Cover 14x29.2cm, VIP Film w/ Elastic Bands & EMM Gel FDA UDI
- Model / Reference
- Intraoperative PU Probe Cover EUDAMEDE6361 EUDAMEDFDA UDI
- Description
- Probe Cover 14x29.2cm, VIP Film w/ Elastic Bands & EMM Gel FDA UDI
Identifiers
- Catalog Number
- E6361 FDA UDI
- Primary DI / UDI-DI
- 06975085708360 EUDAMEDFDA UDI
- Basic UDI-DI
- 697542419EC49JB EUDAMED
- 510(k) Number
- K211969 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
- GMDN Term
- Body-surface ultrasound imaging transducer cover FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Intraoperative PU Probe Cover by Exact Medical Manufacturing, Inc — Class IIa — 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 | 697542419EC49JB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 494e23e9-ef46-47d3-a56c-4505490edb9e 61 fields · synced Jun 18, 2026
- FDA UDI 7d0735b3-f478-4a68-92b7-2430ba72627a 35 fields · synced May 30, 2026