Identity
- Trade Name
- ERBE MONOPlate 40 EUDAMEDERBE FDA UDI
- Generic Name
- Electrosurgical return electrode, single-use FDA UDI
- Device Name
- MONO Plate, SU EUDAMEDERBE MONOPlate 40 single; 40cm² FDA UDI
- Model / Reference
- 20193-073 EUDAMEDFDA UDI
- Description
- ERBE MONOPlate 40 single; 40cm² FDA UDI
Identifiers
- Catalog Number
- 20193-073 FDA UDI
- Primary DI / UDI-DI
- 04050147005150 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04050147005150 EUDAMED
- 510(k) Number
- K972269 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K02010202 ELECTROSURGERY DUAL PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE EUDAMED
- GMDN Term
- Electrosurgical return electrode, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany 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
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
Dimensions & Sizes
- Size
- Area/Surface Area — 40.000 Square centimeter FDA UDI
Category: Electrosurgical return electrode, single-use
Erbe by Erbe Elektromedizin GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical return electrode, single-use.
- MediMax Tech — MEDIMAX TECH INC. · Class II
- MediMax Tech — MEDIMAX TECH INC. · Class II
- Blayco — Telic, S.A.U. · Class IIb
- CATHAY — CATHAY MANUFACTURING CORP. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Blayco — Telic, S.A.U. · Class IIb
- Swaroplate — NISSHA MEDICAL TECHNOLOGIES SAS · Class II
- Bio Protech — BIO PROTECH USA, INC. · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | 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
- Erbe Elektromedizin GmbH
Sources (2)
- FDA UDI b77967dc-4798-49d9-aa5a-8d83eb69dd74 38 fields · synced Jun 19, 2026
- EUDAMED 327d37e7-0ed2-41a4-bdf3-782c17c11493 61 fields · synced Jun 14, 2026