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SafetiHEEL

by NSP Tech Pte Ltd 2 variants

Ref SH-100Model SH-065

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8887629SH4Y Basic UDI-DI 08887629010236UDI-DIDate3 Jun 2026RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number08887629010236 UDI-DI Date29 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Blood lancet, single-use
Model / Reference
SH-065, SH-100
Primary DI / UDI-DI
08887629010236 EUDAMED
08887629010205 GUDID
Basic UDI-DI
8887629SH4Y
Unit of Use DI
08887629010205
510(k) Number
FDA Product Code
FMK
EMDN Code
V010401 Lancets with safety systems, single-use
GMDN Term
Blood lancet, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4850
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization
Size
Depth — 100 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08887629010236
GUDID
08887629010205
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
SG-MF-000039822
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Nsp Tech Pte, Ltd.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No