Identity
- Trade Name
- TOCO TRANSDUCER WATERTIGHT BUTTON AND LOOP EUDAMEDTOCO TRANSDUCER FDA UDI
- Generic Name
- Tocodynamometer probe FDA UDI
- Device Name
- TOCO Transducer EUDAMED
- Model / Reference
- 2108347-001 EUDAMEDNA FDA UDI
Identifiers
- Catalog Number
- 2108347 FDA UDI
- Primary DI / UDI-DI
- 00840682142571 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00130GS EUDAMED
- Direct Marketing DI
- 00840682142571 EUDAMED
- 510(k) Number
- K982651 FDA UDI
- FDA Product Code
- HFM FDA UDI
- EMDN Code
- Z1208010403 TRANSMITTING UNITS FOR CARDIOTOCOGRAPHIC TELEMETRY EUDAMED
- GMDN Term
- Tocodynamometer probe FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.2720 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tocodynamometer probe
Toco Transducer by Wipro GE Healthcare Private Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tocodynamometer probe.
- Cetro America Toco Transducer for all Coro models, Waterproof — Cetro America · Class II
- Cetro America Toco Transducer for all Coro models — Cetro America · Class II
- TOCO Transducer — Edan Instruments, Inc. · Class II
- FEATHERLITE TOCO — Parker Hannifin Corp. · Class II
- Cetro America Toco Transducer for HP 1350+, Waterproof — Cetro America · Class II
- Avalon TOCO MP Transducer — Philips Medizin Systeme Böblingen GmbH · Class II
- FEATHERLITE AQUA — Parker Hannifin Corp. · Class II
- FEATHERLITE TOCO — Parker Hannifin Corp. · Class II
Cleared under the same submission
K982651 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wipro GE Healthcare Private Ltd
Sources (2)
- FDA UDI a76c33c6-5358-4d51-90a6-a8a40949c328 36 fields · synced Jun 18, 2026
- EUDAMED 97d15e10-e358-4354-925e-c57d59eeac76 61 fields · synced Jun 18, 2026