Identity
- Trade Name
- Eclipse 3D Probe Cover EUDAMEDECLIPSE FDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDI
- Device Name
- Eclipse Probe Cover EUDAMEDEclipse Probe Cover, 83mm/43x241mm FDA UDI
- Model / Reference
- 38-01 EUDAMED38-03 EUDAMEDPROBE COVER-LATEX FREE FDA UDI
- Description
- Eclipse Probe Cover, 83mm/43x241mm FDA UDI
Identifiers
- Catalog Number
- 38-03 FDA UDI
- Primary DI / UDI-DI
- 10855683006354 EUDAMEDFDA UDI
- Basic UDI-DI
- 085568300638000K5 EUDAMED
- Unit of Use DI
- 00855683006357 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 3D 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 1d7215a1-d791-4d97-8cb3-1561aee5d840 61 fields · synced Jun 19, 2026
- FDA UDI 3e2e3f0e-d53b-4449-ad1b-7ec39fc3ae73 36 fields · synced May 30, 2026