Identity
- Trade Name
- Eclipse Probe Cover EUDAMEDFDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDI
- Device Name
- Eclipse Probe Cover EUDAMEDA soft disposable ultrasound probe cover FDA UDI
- Model / Reference
- 38-01 EUDAMED38-01-1 EUDAMEDFDA UDI
- Description
- A soft disposable ultrasound probe cover FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10855683006866 EUDAMEDFDA UDI
- Basic UDI-DI
- 085568300638000K5 EUDAMED
- 510(k) Number
- K953673 FDA UDI
- FDA Product Code
- IYO FDA UDI
- EMDN Code
- Z11049085 VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Body-surface ultrasound imaging transducer cover FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Market of Registration
- Netherlands 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Eclipse Probe Cover by Parker Laboratories, 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 | 085568300638000K5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parker Laboratories, Inc.
- EUDAMED SRN
- US-MF-000013857
- Authorised Representative
- Parker Laboratories, BV NL-AR-000012618
Sources (2)
- EUDAMED cb2eb4b6-efda-4ebc-af36-464908ba7851 61 fields · synced Jun 19, 2026
- FDA UDI b7d0efaf-b77f-48ed-a4f5-95ca52946222 35 fields · synced May 30, 2026