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SBPM cuff
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 04041346101231Model HBPM Cuff
by I.E.M. GmbH
Identity
- Trade Name
- Tel-O-Graph® Manschette XL EUDAMEDSBPM cuff FDA UDI
- Generic Name
- Telemetric sphygmomanometer FDA UDI
- Device Name
- HBPM Cuff EUDAMED
- Model / Reference
- HBPM Cuff EUDAMED04041346101231 EUDAMEDsize XL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04041346101231 EUDAMEDFDA UDI
- Basic UDI-DI
- 40413461009536 EUDAMED
- Direct Marketing DI
- 04041346101231 EUDAMED
- 510(k) Number
- K173895 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020685 VITAL SIGNS TELEMETRY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Telemetric sphygmomanometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Telemetric sphygmomanometer
SBPM cuff by I.E.M. GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Telemetric sphygmomanometer.
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Cleared under the same submission
K173895 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
- I.E.M. GmbH
Sources (2)
- FDA UDI 086cd7fb-c10f-46c9-9b97-9d599f49f633 33 fields · synced Jun 18, 2026
- EUDAMED aa8641e8-976c-453f-9bb4-1e406ebbf39e 61 fields · synced Jun 18, 2026