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NIBP Cuffs

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 2.120021Model BPCV14XS - Velcro cuff XS 

by Schiller Ag

Identity

Trade Name
NIBP Cuffs EUDAMED
NIBP MCF CV 10-19 BA INF EUDAMED
Schiller NIBP cuff FDA UDI
Generic Name
Blood pressure cuff, reusable FDA UDI
Device Name
BPCV14XS EUDAMED
NIBP MCF CV 10-19 BA INF FDA UDI
Model / Reference
BPCV14XS - Velcro cuff XS EUDAMED
2.120021 EUDAMEDFDA UDI
Description
NIBP MCF CV 10-19 BA INF FDA UDI

Identifiers

Primary DI / UDI-DI
07613365000535 EUDAMEDFDA UDI
Basic UDI-DI
761336500000000452 EUDAMED
Direct Marketing DI
07613365000535 EUDAMED
510(k) Number
K012226 FDA UDI
K221056 FDA UDI
FDA Product Code
DXQ FDA UDI
EMDN Code
Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
GMDN Term
Blood pressure cuff, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
870.1120 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

NIBP Cuffs by Schiller AG — 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

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Manufacturer

Manufacturer
Schiller Ag
EUDAMED SRN
CH-MF-000012722
Authorised Representative
SCHILLER Medizintechnik GmbH DE-AR-000006934

Sources (3)

  • EUDAMED ab6cd123-989e-4fc4-a5a8-456197831be1 61 fields · synced Jun 20, 2026
  • FDA UDI 3c54e1ff-525e-4bb9-914d-c7b2e08db9b2 36 fields · synced May 29, 2026
  • EUDAMED 5f167e10-25bc-498c-b20a-c5fef7b4c680 61 fields · synced Jun 20, 2026