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NIBP cuff

EUDAMEDFDA UDI

Class I (EU MDR)

Ref BPN-20ND-G004Ref BPN-50ND-G004Ref BPNW-20NSRef BPN-10ND-W1011Ref BP-30NS-W01PRef BP-40BS-W44Ref BPN-30ND-G004Ref BP-80BS-W44Ref BPD-30TS-W10Ref BPD-30WSRef BP-30NS-W01MRef BP-30ND-WD08Ref BP-80NS-W08Ref BPD-20TS-W08Ref BPD-20TD-WD08Ref BP-70BS-W10Ref BPD-12TS-W05Ref BP-50BS-W08Ref BP-60BS-W01MRef BP-80ND-WD08Ref BPD-15WSRef BPD-15TS-W05PRef BPD-13TS-W36Ref BPD-20WDRef BP-50BDRef BP-30BD-WD11Ref BP-20NS-W08Ref BPN-20NS-W01MRef BPD-80TS-W08Ref BP-20BS-W08Ref BPN-50ND-W1011Ref BPN-30BSRef BP-70NS-W01MRef BPN-90NS-W10

by Orantech Inc.

Identity

Trade Name
NIBP cuff EUDAMED
Orantech FDA UDI
Generic Name
Blood pressure cuff, single-use FDA UDI
Blood pressure cuff, reusable FDA UDI
Device Name
NIBP cuff EUDAMED
Soft fiber, Double tube, Infant Range 9.0-14.8cm FDA UDI
Dark blue nylon, Bladderless, Single tube, With connector Infant Range 9.0-14.8cm FDA UDI
TPU, Single tube, With connector Neonatal #5 Range 8-15cm FDA UDI
Coffee PU leather, With inflation bag, Single tube Child Range 18-26cm FDA UDI
Soft fiber, Single tube, Child Range 13.8-21.5cm FDA UDI
With inflation bag, Single tube, With connector Adult Extra Long Range 23-46cm FDA UDI
Bladderless, Double tube, With connector Large Adult Long Range 35.5-59cm FDA UDI
Bladderless, Single tube, With connector Large Adult Long Range 35.5-59cm FDA UDI
Soft fiber, Single tube, Neonatal #5 Range 8-15cm FDA UDI
TPU, Single tube, With connector Neonatal #3 Range 6-11cm FDA UDI
With inflation bag, Single tube, With connector Infant Range 8-13cm FDA UDI
With inflation bag, Single tube, With connector Large Adult Range 31-40cm FDA UDI
Bladderless, Single tube, With connector Large Adult Range 35.5-46cm FDA UDI
Dark blue nylon, Bladderless, Single tube, With connector Adult Range 27.5-36.5cm FDA UDI
TPU, Single tube, With connector Child Range 13.8-21.5cm FDA UDI
Bladderless, Single tube, With connector Child Range 13.8-21.5cm FDA UDI
TPU, Single tube, With connector Large Adult Long Range 35.5-59cm FDA UDI
Bladderless, Single tube, With connector Infant Range 9.0-14.8cm FDA UDI
With inflation bag, Single tube, With connector Adult Range 23-33cm FDA UDI
TPU, Double tube, With connector Infant Range 9.0-14.8cm FDA UDI
With inflation bag, Double tube Adult Range 23-33cm FDA UDI
Bladderless, Double tube, With connector Child Range 13.8-21.5cm FDA UDI
TPU, Single tube, With connector Infant Range 9.0-14.8cm FDA UDI
TPU, Single tube, With connector Neonatal #2 Range 4-8cm FDA UDI
With inflation bag, Double tube, With connector Child Range 12-19cm FDA UDI
Model / Reference
BPN-20ND-G004 EUDAMED
BPN-50ND-G004 EUDAMED
BPNW-20NS EUDAMED
BPN-10ND-W1011 EUDAMED
BP-30NS-W01P EUDAMED
BP-40BS-W44 EUDAMED
BPN-30ND-G004 EUDAMED
BP-80BS-W44 EUDAMED
BPD-30TS-W10 EUDAMEDFDA UDI
BPD-20WD EUDAMEDFDA UDI
BPN-20NS-W01M EUDAMEDFDA UDI
BPD-15TS-W05P EUDAMEDFDA UDI
BPN-30BS EUDAMEDFDA UDI
BPD-30WS EUDAMEDFDA UDI
BP-60BS-W01M EUDAMEDFDA UDI
BP-80ND-WD08 EUDAMEDFDA UDI
BP-80NS-W08 EUDAMEDFDA UDI
BPD-15WS EUDAMEDFDA UDI
BPD-13TS-W36 EUDAMEDFDA UDI
BP-20BS-W08 EUDAMEDFDA UDI
BP-70BS-W10 EUDAMEDFDA UDI
BP-70NS-W01M EUDAMEDFDA UDI
BPN-50ND-W1011 EUDAMEDFDA UDI
BP-30NS-W01M EUDAMEDFDA UDI
BPD-80TS-W08 EUDAMEDFDA UDI
BP-20NS-W08 EUDAMEDFDA UDI
BP-50BS-W08 EUDAMEDFDA UDI
BPD-20TD-WD08 EUDAMEDFDA UDI
BP-50BD EUDAMEDFDA UDI
BP-30ND-WD08 EUDAMEDFDA UDI
BPD-20TS-W08 EUDAMEDFDA UDI
BP-30BD-WD11 EUDAMEDFDA UDI
BPD-12TS-W05 EUDAMED
BPN-90NS-W10 EUDAMED
BPD-12TS-W05P FDA UDI
Description
Soft fiber, Double tube, Infant Range 9.0-14.8cm FDA UDI
Dark blue nylon, Bladderless, Single tube, With connector Infant Range 9.0-14.8cm FDA UDI
TPU, Single tube, With connector Neonatal #5 Range 8-15cm FDA UDI
Coffee PU leather, With inflation bag, Single tube Child Range 18-26cm FDA UDI
Soft fiber, Single tube, Child Range 13.8-21.5cm FDA UDI
With inflation bag, Single tube, With connector Adult Extra Long Range 23-46cm FDA UDI
Bladderless, Double tube, With connector Large Adult Long Range 35.5-59cm FDA UDI
Bladderless, Single tube, With connector Large Adult Long Range 35.5-59cm FDA UDI
Soft fiber, Single tube, Neonatal #5 Range 8-15cm FDA UDI
TPU, Single tube, With connector Neonatal #3 Range 6-11cm FDA UDI
With inflation bag, Single tube, With connector Infant Range 8-13cm FDA UDI
With inflation bag, Single tube, With connector Large Adult Range 31-40cm FDA UDI
Bladderless, Single tube, With connector Large Adult Range 35.5-46cm FDA UDI
Dark blue nylon, Bladderless, Single tube, With connector Adult Range 27.5-36.5cm FDA UDI
TPU, Single tube, With connector Child Range 13.8-21.5cm FDA UDI
Bladderless, Single tube, With connector Child Range 13.8-21.5cm FDA UDI
TPU, Single tube, With connector Large Adult Long Range 35.5-59cm FDA UDI
Bladderless, Single tube, With connector Infant Range 9.0-14.8cm FDA UDI
With inflation bag, Single tube, With connector Adult Range 23-33cm FDA UDI
TPU, Double tube, With connector Infant Range 9.0-14.8cm FDA UDI
With inflation bag, Double tube Adult Range 23-33cm FDA UDI
Bladderless, Double tube, With connector Child Range 13.8-21.5cm FDA UDI
TPU, Single tube, With connector Infant Range 9.0-14.8cm FDA UDI
TPU, Single tube, With connector Neonatal #2 Range 4-8cm FDA UDI
With inflation bag, Double tube, With connector Child Range 12-19cm FDA UDI

Identifiers

Primary DI / UDI-DI
06941691981572 EUDAMED
06941691981602 EUDAMED
06941691981701 EUDAMED
06941691981466 EUDAMED
06941691974932 EUDAMED
06941691961871 EUDAMED
06941691981589 EUDAMED
06941691961901 EUDAMED
06941691900627 EUDAMEDFDA UDI
06941691900276 EUDAMEDFDA UDI
06941691965923 EUDAMEDFDA UDI
06941691900399 EUDAMEDFDA UDI
06941691963158 EUDAMEDFDA UDI
06941691900153 EUDAMEDFDA UDI
06970706368442 EUDAMEDFDA UDI
06970706369630 EUDAMEDFDA UDI
06970706369364 EUDAMEDFDA UDI
06941691900139 EUDAMEDFDA UDI
06941691900429 EUDAMEDFDA UDI
06970706368589 EUDAMEDFDA UDI
06970706368725 EUDAMEDFDA UDI
06970706369173 EUDAMEDFDA UDI
06941691974307 EUDAMEDFDA UDI
06970706369135 EUDAMEDFDA UDI
06941691900597 EUDAMEDFDA UDI
06970706369302 EUDAMEDFDA UDI
06970706368619 EUDAMEDFDA UDI
06941691900825 EUDAMEDFDA UDI
06970706368169 EUDAMEDFDA UDI
06970706369586 EUDAMEDFDA UDI
06941691900535 EUDAMEDFDA UDI
06941691900368 EUDAMEDFDA UDI
06970706369043 EUDAMEDFDA UDI
06941691981473 EUDAMED
Basic UDI-DI
69416919ORANTECH06QZ EUDAMED
510(k) Number
K173197 FDA UDI
FDA Product Code
DXQ FDA UDI
EMDN Code
Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
GMDN Term
Blood pressure cuff, single-use FDA UDI
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
Denmark EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

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

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose multi-parameter bedside monitor

NIBP cuff by Orantech Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose multi-parameter bedside monitor.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Orantech Inc.
EUDAMED SRN
CN-MF-000013859
Authorised Representative
Medten EU ApS DK-AR-000034434

Sources (59)

  • EUDAMED 5ef7d787-2b9a-4fd1-b522-0764d814257d 61 fields · synced Sep 18, 2026
  • EUDAMED e2d9955f-d6ba-4831-9b15-5103bfad4f2b 61 fields · synced May 16, 2026
  • EUDAMED ff3c4464-0ba7-4239-a2b5-ed56a4c6eb54 61 fields · synced May 17, 2026
  • EUDAMED 84525337-d9be-40fb-b88e-36c96bf72608 61 fields · synced May 17, 2026
  • EUDAMED 22434c2e-4acd-48ea-9a95-c311731a7617 61 fields · synced May 17, 2026
  • EUDAMED 54f918ee-a03f-44c9-ad79-b68f067c6bd9 61 fields · synced May 17, 2026
  • EUDAMED 6e900f5c-4cee-46b8-9be0-f798980d1970 61 fields · synced May 17, 2026
  • EUDAMED 983ada51-7998-4b32-be18-b6c140af6c46 61 fields · synced May 17, 2026
  • EUDAMED 8a5b98ea-aecd-4fc1-86e3-b19e01574d1f 61 fields · synced May 17, 2026
  • FDA UDI 724e9daa-cbcd-4b74-afd0-35dabaa19e65 34 fields · synced May 29, 2026
  • FDA UDI e11256aa-61ee-4a9b-9e8b-c39a0ad0d359 34 fields · synced May 29, 2026
  • FDA UDI f901096a-8590-4556-8ff2-7c1b7db30595 34 fields · synced May 29, 2026
  • FDA UDI c45bc564-cc52-414f-aa10-e125a368fe12 34 fields · synced May 30, 2026
  • FDA UDI d6644c34-84ba-4aef-aa27-c2880d77a83f 34 fields · synced May 30, 2026
  • FDA UDI 5c7a8065-8d21-4ed1-acef-55f1d000ff09 34 fields · synced May 30, 2026
  • FDA UDI c74b985f-0061-4fe8-931b-03ea86d3a110 34 fields · synced May 30, 2026
  • FDA UDI 7399bbd2-012a-45f4-9684-656726e426a9 34 fields · synced May 30, 2026
  • FDA UDI 67785a6d-bc99-4509-a5f7-475bc4174692 34 fields · synced May 30, 2026
  • FDA UDI c92098d4-c742-44ca-94d0-0d759bc218a2 34 fields · synced May 30, 2026
  • FDA UDI acb37d56-9e2c-4024-b3e0-a626a5c8373e 34 fields · synced May 30, 2026
  • FDA UDI 5e6b4dc9-cdd0-4583-adeb-cb3af4e32482 34 fields · synced May 30, 2026
  • FDA UDI 07ddb178-2bc6-4c94-920e-a2bd9208c5f6 34 fields · synced May 30, 2026
  • FDA UDI 99e30d7c-dbb5-4c45-b486-b7fe6af13067 34 fields · synced May 30, 2026
  • FDA UDI 10be50e6-0470-4082-8fe9-e9602c433463 34 fields · synced May 30, 2026
  • FDA UDI ea08d98c-2fa3-47a7-9706-f987b1a57bcb 34 fields · synced May 30, 2026
  • FDA UDI 3cb81332-1367-4534-82d8-6697dba4f040 34 fields · synced May 30, 2026
  • FDA UDI faf656a4-cc6a-4056-a3ba-9ce65cd07e08 34 fields · synced May 30, 2026
  • FDA UDI 801fc564-c6cd-4499-9bb8-8f74cabae3b3 34 fields · synced May 30, 2026
  • FDA UDI 0fcd23bb-56e2-45f1-a26d-d3ba82f08634 34 fields · synced May 30, 2026
  • FDA UDI 869d6f8e-011e-4c63-8890-c8b34b4a1459 34 fields · synced May 30, 2026
  • FDA UDI 2bed0f6a-1b1e-4bc1-85a5-6b2cbd6fca2a 34 fields · synced May 30, 2026
  • FDA UDI 43174652-fa92-4c03-859f-0f99600d17cf 34 fields · synced May 30, 2026
  • FDA UDI 8a127828-3dc5-43f4-8b18-f29baff7be54 34 fields · synced May 30, 2026
  • FDA UDI ca5fe786-1cea-4e8a-8785-167edfd1a846 34 fields · synced May 30, 2026
  • EUDAMED 05605dcf-7153-4834-aaeb-2f736b62403f 61 fields · synced Jun 20, 2026
  • EUDAMED 6bf327b0-7b31-41ab-bb6e-a58a32c9b616 61 fields · synced Jul 8, 2026
  • EUDAMED d0f625c1-35c9-43a7-9423-3e893e964b00 61 fields · synced Jul 9, 2026
  • EUDAMED b7efee73-010e-434a-aaac-e5527d374746 61 fields · synced Jul 9, 2026
  • EUDAMED 55158b33-59b6-4ed9-8452-c938fba752c6 61 fields · synced Jul 9, 2026
  • EUDAMED f2001a42-e3c0-41b5-a6a3-2f8b550bcdd5 61 fields · synced Jul 10, 2026
  • EUDAMED 830b0ee2-150e-4a8a-9f87-76e72ecbb170 61 fields · synced Jul 11, 2026
  • EUDAMED 34bc7ede-e2e9-4d29-a4e1-be2545ac946e 61 fields · synced Jul 11, 2026
  • EUDAMED 9e3aa8bf-6be6-4c9d-ba68-043e43466b6f 61 fields · synced Jul 12, 2026
  • EUDAMED c3d2697b-5444-4bf9-9472-132b915b77ce 61 fields · synced Jul 15, 2026
  • EUDAMED cd80df1e-fc7b-4d3f-b63c-57791e5996d7 61 fields · synced Jul 15, 2026
  • EUDAMED df65205e-c0e7-438b-b020-6e4e16a43e6b 61 fields · synced Jul 15, 2026
  • EUDAMED 31c5c827-0358-4ca7-a9d5-5cacfab6409b 61 fields · synced Jul 16, 2026
  • EUDAMED d1f02f9b-dcf5-48e3-8b03-1facd97b5b57 61 fields · synced Jul 17, 2026
  • EUDAMED a03452b2-0c72-4a83-9889-950f76d5c33b 61 fields · synced Jul 17, 2026
  • EUDAMED 4c59e2f0-32b8-49ab-bf2f-137211c9f390 61 fields · synced Jul 19, 2026
  • EUDAMED 679fccc0-97ab-4d79-85f6-b53ee96d8982 61 fields · synced Jul 20, 2026
  • EUDAMED 4d06754a-2e23-4d0b-a807-ab1b0e70228d 61 fields · synced Jul 21, 2026
  • EUDAMED 92bee08f-555a-4f4d-b29a-1c1267b13b0c 61 fields · synced Jul 27, 2026
  • EUDAMED 5edb6fe8-648b-4062-abe7-dc944761fc29 61 fields · synced Jul 28, 2026
  • EUDAMED f5012045-0da1-49fd-97eb-d16582ee24e6 61 fields · synced Jul 28, 2026
  • EUDAMED cd0efb8c-631a-4d96-b5ee-4a8ba51c6d3e 61 fields · synced Jul 28, 2026
  • EUDAMED 6975111b-dd24-409d-bea2-65dabf3cb14e 61 fields · synced Jul 29, 2026
  • EUDAMED ad8b9347-bf1c-4768-8ebf-ad4895d0f73d 61 fields · synced Aug 2, 2026
  • EUDAMED 0ec42d2c-9349-45d2-8d57-36471cfe95b0 61 fields · synced Sep 18, 2026