DRAP REGISTERED MEDICAL DEVICE
SPIKE LC S (Bipolar) (Electrocatheters for temporary endocardial pacing and electrophysiological studies) is registered with DRAP under number MDIR-0000788 as a Class D (high risk) medical device, imported. The listed holder is A & E Medical. Its listed renewal date (10 Jun 2024) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0000788
DRAP registered Class B/C/D list, 28 Aug 2025
It may have been renewed after DRAP's last list. Ask the vendor for the renewal letter.
ELI-00023
| Device | SPIKE LC S (Bipolar) (Electrocatheters for temporary endocardial pacing and electrophysiological studies) |
|---|---|
| Class | D |
| Listed holder | A & E Medical |
| Holder address | 323-Ata Turk Block, New Gardan Town, Lahore |
| Manufacturing site | M/s. FIAB SpA Via Paolo Costoli 4, 50039 VICCHIO-Florence-ITALY M/s Via Bruno Passerini 2,3, 4, 6 50039 VICCHIO-Florence-ITALY M/s Via Della Resistenza 18, 50039 VICCHIO-Florence-ITALY |
| Issued | 10 Jul 2019 |
| Renewal date | 10 Jun 2024 |
| Licence | ELI-00023 |
Specifications
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Screened 5 Oct 2026, 08:54 (Pakistan time). A screening aid, not an official DRAP verification.
More devices from this holder
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| MDIR-0001539 | NAMIC Angiographic Manifold | Class B |
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| MDIR-0002324 | Inflation Device [Inflation Device 40 ATM REF# 96346 Inflation Device 55ATM REF# 96463] | Class B |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
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| MDIR-0007657 | SPIKE EASY LC ULTRA SPIKE LC LEADS FOR TEMPORARY CARDIAC PACING | Class D | S.J TRADERS |
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| MDIR-0003625 | Spike (Accessories for HD sterilized by irradiation (e-beam) [5015921] | Class B | Fresenius Medical Care Pakistan (Pvt) Ltd. |
| MDIR-0001203 | AS5010 Flow Art Valve for Bag Access (Vial transfer spike) | Class B | Ever X |
Corrections
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Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.