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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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  • MD Atlas
  • Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.

Data from EUDAMED, last updated Jun 11, 2026

Patient monitor

B-06948309002643

1 reference

Class IIb
Applicable legislation
MDD [Directive 93/42/EEC on medical devices]
Risk category
Class IIb
Manufacturer
Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.

Device family identification

Device name
Patient monitor
Basic UDI-DI
B-06948309002643
Device model
mTouch8
Issuing agency
EUDAMED
Version date
May 13, 2026

Classification

Applicable legislation
MDD [Directive 93/42/EEC on medical devices]
Risk category
Class IIb
Status
On the market

Manufacturer & authorised representative

Manufacturer

Name
Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.
SRN
CN-MF-000031019
Country
China
Email
602367678@qq.com
Phone
+86755 26408541

Authorised representative

Name
Shanghai International Holding Corp. GmbH(Europe)
SRN
DE-AR-000000001
Country
Germany
Phone
+49 40 2513175

Device characteristics

No device characteristics flagged

EMDN code(s)

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

  • Z1203020202Transportable/portable multi–parameter patient monitors

References by status

Legacy certificates

Certificate number
No. G1 071165 0013
Type
refdata.legacy.mdd-certificate-type.ii-4
Notified body
TÜV SÜD Product Service GmbH (0123)
Validity
May 26, 2024

References

1 reference

Export results

Applied filters

  • basicUdiUlid·01KRGCCR5FNY1VZHATS6C3HXYY

Format

Summary

31 columns included
  • Trade name
  • Basic UDI-DI
  • UDI-DI code
  • Risk category
  • Applicable legislation
  • Status
  • Organization name
  • SRN
  • Reference / catalog number
  • Additional product description
  • Intended medical purpose
  • Market country
  • Issuing entity
  • Market info update date
  • Sterile
  • Single use
  • Contains latex
  • Reprocessed single-use
  • Direct marking
  • CMR substance
  • Endocrine disruptor
  • Annex XVI applicable
  • Sterilization
  • OEM applicable
  • EMDN codes
  • Last updated
  • Basic UDI-DI device name
  • Basic UDI-DI device model
  • Basic UDI-DI implantable
  • Basic UDI-DI reagent
  • DM Atlas link
Trade nameReference / catalog numberUDI-DI codeQuantityStatus
Patient monitormTouch8069483090026431On the market